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Sample records for ophthalmic solutions

  1. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous solution including suitable and harmless preservatives and buffer substances, contains 10 milligrams...

  2. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Kanamycin ophthalmic aqueous solution. 524.1200b... § 524.1200b Kanamycin ophthalmic aqueous solution. (a) Specifications. The drug, which is in an aqueous solution including suitable and harmless preservatives and buffer substances, contains 10 milligrams...

  3. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Gentamicin ophthalmic solution. 524.1044a Section... § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsor. See No....

  4. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Gentamicin ophthalmic solution. 524.1044a Section... § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsor. See No....

  5. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Gentamicin ophthalmic solution. 524.1044a Section... § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsor. See No....

  6. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Gentamicin ophthalmic solution. 524.1044a Section... § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsor. See No....

  7. 21 CFR 524.1044a - Gentamicin ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Gentamicin ophthalmic solution. 524.1044a Section... § 524.1044a Gentamicin ophthalmic solution. (a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsor. See No....

  8. 21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Proparacaine hydrochloride ophthalmic solution. 524.1982 Section 524.1982 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1982...

  9. Ophthalmic regional blocks: management, challenges, and solutions

    PubMed Central

    Palte, Howard D

    2015-01-01

    In the past decade ophthalmic anesthesia has witnessed a major transformation. The sun has set on the landscape of ophthalmic procedures performed under general anesthesia at in-hospital settings. In its place a new dawn has ushered in the panorama of eye surgeries conducted under regional and topical anesthesia at specialty eye care centers. The impact of the burgeoning geriatric population is that an increasing number of elderly patients will present for eye surgery. In order to accommodate increased patient volumes and simultaneously satisfy administrative initiatives directed at economic frugality, administrators will seek assistance from anesthesia providers in adopting measures that enhance operating room efficiency. The performance of eye blocks in a holding suite meets many of these objectives. Unfortunately, most practicing anesthesiologists resist performing ophthalmic regional blocks because they lack formal training. In future, anesthesiologists will need to block eyes and manage common medical conditions because economic pressures will eliminate routine preoperative testing. This review addresses a variety of topical issues in ophthalmic anesthesia with special emphasis on cannula and needle-based blocks and the new-generation antithrombotic agents. In a constantly evolving arena, the sub-Tenon’s block has gained popularity while the deep angulated intraconal (retrobulbar) block has been largely superseded by the shallower extraconal (peribulbar) approach. Improvements in surgical technique have also impacted anesthetic practice. For example, phacoemulsification techniques facilitate the conduct of cataract surgery under topical anesthesia, and suture-free vitrectomy ports may cause venous air embolism during air/fluid exchange. Hyaluronidase is a useful adjuvant because it promotes local anesthetic diffusion and hastens block onset time but it is allergenic. Ultrasound-guided eye blocks afford real-time visualization of needle position and local

  10. Ophthalmic regional blocks: management, challenges, and solutions.

    PubMed

    Palte, Howard D

    2015-01-01

    In the past decade ophthalmic anesthesia has witnessed a major transformation. The sun has set on the landscape of ophthalmic procedures performed under general anesthesia at in-hospital settings. In its place a new dawn has ushered in the panorama of eye surgeries conducted under regional and topical anesthesia at specialty eye care centers. The impact of the burgeoning geriatric population is that an increasing number of elderly patients will present for eye surgery. In order to accommodate increased patient volumes and simultaneously satisfy administrative initiatives directed at economic frugality, administrators will seek assistance from anesthesia providers in adopting measures that enhance operating room efficiency. The performance of eye blocks in a holding suite meets many of these objectives. Unfortunately, most practicing anesthesiologists resist performing ophthalmic regional blocks because they lack formal training. In future, anesthesiologists will need to block eyes and manage common medical conditions because economic pressures will eliminate routine preoperative testing. This review addresses a variety of topical issues in ophthalmic anesthesia with special emphasis on cannula and needle-based blocks and the new-generation antithrombotic agents. In a constantly evolving arena, the sub-Tenon's block has gained popularity while the deep angulated intraconal (retrobulbar) block has been largely superseded by the shallower extraconal (peribulbar) approach. Improvements in surgical technique have also impacted anesthetic practice. For example, phacoemulsification techniques facilitate the conduct of cataract surgery under topical anesthesia, and suture-free vitrectomy ports may cause venous air embolism during air/fluid exchange. Hyaluronidase is a useful adjuvant because it promotes local anesthetic diffusion and hastens block onset time but it is allergenic. Ultrasound-guided eye blocks afford real-time visualization of needle position and local

  11. Diquafosol ophthalmic solution 3 %: a review of its use in dry eye.

    PubMed

    Keating, Gillian M

    2015-05-01

    Diquafosol ophthalmic solution 3 % (Diquas(®)) is a P2Y2 receptor agonist that promotes tear fluid and mucin secretion and is currently approved in Japan and South Korea for the treatment of dry eye. In randomized, double-blind, multicentre trials in patients with dry eye, significantly greater improvements in fluorescein and rose bengal staining scores were seen with diquafosol ophthalmic solution 3 % than with placebo, and diquafosol ophthalmic solution 3 % was noninferior to sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the fluorescein staining score and more effective than sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the rose bengal staining score. The efficacy of diquafosol ophthalmic solution 3 % in the treatment of dry eye was maintained in the longer term, with improvements also seen in subjective dry eye symptoms, and was also shown in a real-world setting. Diquafosol ophthalmic solution 3 % also demonstrated efficacy in various specific dry eye disorders, including aqueous-deficient dry eye, short tear film break-up time dry eye, obstructive meibomian gland dysfunction, dry eye following laser in situ keratomileusis surgery and dry eye following cataract surgery, as well as in contact lens wearers and visual display terminal users. Diquafosol ophthalmic solution 3 % was generally well tolerated in patients with dry eye, with eye irritation the most commonly reported adverse event. In conclusion, diquafosol ophthalmic solution 3 % is a useful option for the treatment of dry eye. PMID:25968930

  12. Tafluprost Ophthalmic Solution 0.0015 %: A Review in Glaucoma and Ocular Hypertension.

    PubMed

    Keating, Gillian M

    2016-06-01

    Tafluprost ophthalmic solution 0.0015 % preserved with benzalkonium chloride (BAK) 0.001 % is available in several Asian countries, including Japan. In pivotal trials, BAK-preserved tafluprost ophthalmic solution 0.0015 % lowered intraocular pressure (IOP) more effectively than placebo in Asian patients with normal-tension glaucoma and was at least as effective as latanoprost ophthalmic solution 0.005 % in Asian patients with primary open-angle glaucoma or ocular hypertension. In other prospective studies in Asian patients with glaucoma or ocular hypertension, tafluprost ophthalmic solution 0.0015 % was at least as effective as latanoprost ophthalmic solution 0.005 % or travoprost ophthalmic solution 0.004 % in terms of IOP lowering, and was considered easier to use and/or store. The efficacy of tafluprost ophthalmic solution 0.0015 % was maintained in the longer term. Tafluprost ophthalmic solution 0.0015 % was generally well tolerated. In conclusion, BAK-preserved tafluprost ophthalmic solution 0.0015 % remains a useful option for the treatment of Asian patients with glaucoma and ocular hypertension. PMID:27225879

  13. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Gentamicin and betamethasone ophthalmic solution... NEW ANIMAL DRUGS § 524.1044i Gentamicin and betamethasone ophthalmic solution. (a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg)...

  14. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Gentamicin and betamethasone ophthalmic solution... NEW ANIMAL DRUGS § 524.1044i Gentamicin and betamethasone ophthalmic solution. (a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg)...

  15. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Gentamicin and betamethasone ophthalmic solution... NEW ANIMAL DRUGS § 524.1044i Gentamicin and betamethasone ophthalmic solution. (a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg)...

  16. 21 CFR 524.1044i - Gentamicin and betamethasone ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Gentamicin and betamethasone ophthalmic solution... NEW ANIMAL DRUGS § 524.1044i Gentamicin and betamethasone ophthalmic solution. (a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg)...

  17. 21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Neomycin sulfate and polymyxin B sulfate ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution....

  18. 21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Neomycin sulfate and polymyxin B sulfate ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution....

  19. 21 CFR 524.1484e - Neomycin and polymyxin B ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Neomycin and polymyxin B ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... ANIMAL DRUGS § 524.1484e Neomycin and polymyxin B ophthalmic solution. (a) Specifications....

  20. Development and Effects of FTY720 Ophthalmic Solution on Corneal Allograft Survival

    PubMed Central

    Liu, Zhaochuan; Lin, Haotian; Huang, Chulong; Chen, Wan; Xiang, Wu; Geng, Yu; Chen, Weirong

    2015-01-01

    Fingolimod (FTY720), a novel class of sphingosine 1-phosphate receptor modulators, has received special interest among ophthalmologists, particularly given that oral administration of FTY720 has proven to effectively treat corneal graft rejection in animal models. However, no studies have examined the performance of FTY720 as an ophthalmic solution in reducing corneal rejection in high-risk corneal rejection models, and the stability and ocular irritation profile of FTY720 ophthalmic solution are also unknown. Thus, we developed 0.1%, 0.2% and 0.5% FTY720 ophthalmic solutions and evaluated their chemical stabilities under various storage conditions with high- performance liquid chromatography. To investigate the ocular irritancy of the FTY720 ophthalmic solution, New Zealand albino rabbits were subjected to the Draize test. Furthermore, classic, well-established rat allogenic penetrating keratoplasty models were used to investigate the anti-rejection efficacy of the tested FTY720 ophthalmic solutions. We found that the non-irritating 0.5% FTY720 ophthalmic solution could prolong corneal allograft survival in rats with significant efficacy for about one month. Furthermore, no significant concentration changes occurred in any of the types of FTY720 ophthalmic solutions within three months. These results revealed crucial profiles of FTY720 ophthalmic solutions and warrant further investigation and optimization of FTY720 in the anti-rejection therapy after keratoplasty. PMID:26558849

  1. Ciprofloxacin Ophthalmic

    MedlinePlus

    Ciprofloxacin ophthalmic solution is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of ... in the clear front part of the eye). Ciprofloxacin ophthalmic ointment is used to treat conjunctivitis. Ciprofloxacin ...

  2. 21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Neomycin sulfate and polymyxin B sulfate ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND...

  3. 21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Neomycin sulfate and polymyxin B sulfate ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND...

  4. 21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Conditions of use. (1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures...

  5. 21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Conditions of use. (1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures...

  6. 21 CFR 524.1982 - Proparacaine hydrochloride ophthalmic solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Conditions of use. (1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures...

  7. Prolonged increase in tear meniscus height by 3% diquafosol ophthalmic solution in eyes with contact lenses

    PubMed Central

    Nagahara, Yukiko; Koh, Shizuka; Nishida, Kohji; Watanabe, Hitoshi

    2015-01-01

    Purpose This study aimed to evaluate the increase in tear meniscus height (TMH) induced by 3% diquafosol ophthalmic solution in eyes with contact lens (CL). Methods Ten healthy subjects wearing high-water-content CLs received topical instillation of two ophthalmic solutions – 3% diquafosol ophthalmic solution in one eye and artificial tears in the other eye. Lower TMH was measured at 5 minutes, 10 minutes, 15 minutes, 30 minutes, and 60 minutes after instillation by anterior segment optical coherence tomography. Results TMH increased significantly (P<0.001) at 5 minutes and 15 minutes after instillation of saline compared with the baseline values. After instillation of 3% diquafosol ophthalmic solution, TMH significantly increased (P<0.05) at 5 minutes, 15 minutes, 30 minutes, and 60 minutes compared with the baseline values. Increases in TMH after diquafosol instillation were significantly greater (P<0.05) at 15 minutes, 30 minutes, and 60 minutes than increases in TMH after saline instillation. Conclusion Topical instillation of 3% diquafosol ophthalmic solution increases TMH for up to 60 minutes in eyes with high-water-content CLs. PMID:26089634

  8. Cyclopentolate Ophthalmic

    MedlinePlus

    ... ciliary muscle of the eye) before an eye examination. Cyclopentolate is in a class of medications called ... solution into the eye(s) prior to an eye examination.Cyclopentolate ophthalmic may take about a half an ...

  9. Gatifloxacin Ophthalmic

    MedlinePlus

    Gatifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pinkeye; infection of the membrane that covers the outside ... contact lenses while you have symptoms of bacterial conjunctivitis or while you are applying eye drops. you ...

  10. Moxifloxacin Ophthalmic

    MedlinePlus

    Moxifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pink eye; infection of the membrane that covers ... contact lenses while you have symptoms of bacterial conjunctivitis. you should know that bacterial conjunctivitis spreads easily. ...

  11. Review of Azithromycin Ophthalmic 1% Solution (AzaSite®) for the Treatment of Ocular Infections

    PubMed Central

    Opitz, Dominick L.; Harthan, Jennifer S.

    2012-01-01

    AzaSite® (azithromomycin 1.0%) ophthalmic solution was approved in 2007 by the US Food and Drug Administration (FDA) as the first commercially available formulation of ophthalmic azithromycin for the treatment of bacterial conjunctivitis. AzaSite® utilizes a vehicle delivery system called DuraSite®, which stabilizes and sustains the release of azithromycin to the ocular surface, leading to a longer drug residence time, less frequent dosing, and an increase in patient compliance. AzaSite® is a broad spectrum antibiotic, effective against Gram-positive, Gram-negative, and atypical bacteria. AzaSite® has been studied for the treatment of ocular conditions beyond its clinical indication. A number of clinical studies have evaluated its efficacy and safety in the management of ocular conditions such as bacterial conjunctivitis and blepharitis on both the pediatric and adult populations. This article aims to evaluate the peer-reviewed published literature on the use of azithromycin 1.0% ophthalmic for current and possible future ophthalmic uses. PMID:23650453

  12. Impact of deep freezing on the stability of 25 mg/ml vancomycin ophthalmic solutions.

    PubMed

    Sautou-Miranda, V; Libert, F; Grand-Boyer, A; Gellis, C; Chopineau, J

    2002-03-01

    For the treatment of certain eye infections, ophthalmic solutions 'laced' with 25 mg/ml vancomycin are sometimes prepared. Their physical and chemical stability and the maintenance of their sterility were studied after deep freezing at -20 +/- 2 degrees C and thawing, followed or not by refrigeration for 48 h at 4 +/- 2 degrees C. Physical and chemical analysis comprised visual inspection turbidity, determination of pH and osmolality, and assay of vancomycin by high performance liquid chromatography with ultraviolet detection. For microbiological analysis a 25 mg/ml vancomycin ophthalmic solution was filtered through two membranes and cultured on trypticase-soy and Sabouraud-glucose solid media. Any colonies were then counted. These physical, chemical and microbiological analyses demonstrated the stability of 25 mg/ml vancomycin ophthalmic solutions in 5% glucose deep frozen at -20 +/- 2 degrees C for 3 months. The vancomycin concentration varied by no more than 5% of the initial concentration, and no breakdown product was evidenced. Neither pH (mean=3.8 +/- 0.1) nor osmolality (mean=318.3 +/- 5.6 mOsm/kg) varied significantly, and remained compatible with intraocular administration. No particle or bacterial combination was found in the course of the study. The thawing procedure (at ambient temperature or under warm running water from a tap) did not modify the stability of the eye drops. Likewise, storage in a refrigerator for 48 h after thawing did not modify stability. The advantage of storing vancomycin 25 mg/ml ophthalmic solutions for 3 months in deep freeze is that a stock of chemically and microbiologically controlled preparations can be held ready for administration to patients, thereby allowing prompter dispensing, as the eye drops are not made up extemporaneously, while the improved control over production ensures that patients receive solutions of constant quality, as every batch prepared is systematically inspected. PMID:11839451

  13. Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes

    PubMed Central

    Koh, Shizuka

    2015-01-01

    Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT)”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. PMID:26028958

  14. Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence.

    PubMed

    Rajpal, Rajesh K; Ross, Bryan; Rajpal, Sachin D; Hoang, Khoa

    2014-01-01

    Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used by clinicians to manage ocular inflammation and pain following cataract surgery. Over the past decade, the US Food and Drug Administration has approved multiple topical NSAIDs for these purposes, including several reformulated products. One of these medications, bromfenac ophthalmic solution, has a long and extensive history, with proven efficacy and safety in patients following cataract surgery. The evolution of bromfenac ophthalmic solution over the years has involved either lowering the concentration of the active ingredient or extending the dosing interval to improve patient adherence/compliance. This review will focus on the history and progression of bromfenac ophthalmic solution and report the available patient preference and adherence data regarding this ocular NSAID throughout its evolution. PMID:25028541

  15. Evaluation of analgesic efficacy of bromfenac sodium ophthalmic solution 0.09% versus ketorolac tromethamine ophthalmic solution 0.5% following LASEK or Epi-LASIK

    PubMed Central

    Wang, Xiao Jing; Wong, Sze H; Givergis, Roshan; Chynn, Emil W

    2011-01-01

    Background To evaluate the analgesic efficacy of bromfenac sodium ophthalmic solution 0.09% compared with ketorolac tromethamine ophthalmic solution 0.5% in laser epithelial keratomileusis (LASEK) or epithelial keratomileusis (epi-LASEK), sometimes referred to as epi-LASIK. Methods Eighty eyes (from 40 patients, 18 men and 22 women) undergoing bilateral simultaneous LASEK or epi-LASEK were randomized to receive ketorolac in one eye and bromfenac in the other. Mean age was 33.13 ± 9.34 years. One drop of bromfenac or ketorolac was instilled in each eye 15 minutes and one minute prior to surgery, and two and four hours following surgery. Patients were instructed to instill the medications on-label each day through postoperative day 4. The subjects completed pain and visual blurriness assessments from day of surgery to postoperative day 4. Uncorrected visual acuity was tested on postoperative days 1 and 6. Results For each of the five days, pain scores for bromfenac-treated eyes were significantly less than that for ketorolac-treated eyes (P < 0.01). Of the 40 patients, 32 (80%) said bromfenac provided better postoperative analgesia than ketorolac. There was no statistically significant difference in visual blurriness scores between the two groups (P > 0.1). Uncorrected visual acuity did not vary significantly between the treatment groups (P > 0.1). No serious adverse events were noted. Conclusion Bromfenac is subjectively superior to ketorolac in reducing postoperative pain following LASEK or epi-LASEK. The subjects tolerated the drugs well with no serious adverse outcomes and no difference in uncorrected visual acuity. PMID:22034570

  16. Tafluprost Ophthalmic

    MedlinePlus

    ... your doctor.Tafluprost ophthalmic comes in single-use containers. The solution from one container should be used immediately after opening for one or both eyes. Throw away each single-use container and any remaining solution after one use.Tafluprost ...

  17. Sustained intraocular pressure reduction throughout the day with travoprost ophthalmic solution 0.004%

    PubMed Central

    Dubiner, Harvey B; Noecker, Robert

    2012-01-01

    Background The purpose of this study was to characterize intraocular pressure (IOP) reduction throughout the day with travoprost ophthalmic solution 0.004% dosed once daily in the evening. Methods The results of seven published, randomized clinical trials including at least one arm in which travoprost 0.004% was dosed once daily in the evening were integrated. Means (and standard deviations) of mean baseline and on-treatment IOP, as well as mean IOP reduction and mean percent IOP reduction at 0800, 1000, and 1600 hours at weeks 2 and 12 were calculated. Results From a mean baseline IOP ranging from 25.0 to 27.2 mmHg, mean IOP on treatment ranged from 17.4 to 18.8 mmHg across all visits and time points. Mean IOP reductions from baseline ranged from 7.6 to 8.4 mmHg across visits and time points, representing a mean IOP reduction of 30%. Results of the safety analysis were consistent with the results from the individual studies for travoprost ophthalmic solution 0.004%, with ocular hyperemia being the most common side effect. Conclusion Travoprost 0.004% dosed once daily in the evening provides sustained IOP reduction throughout the 24-hour dosing interval in subjects with ocular hypertension or open-angle glaucoma. No reduction of IOP-lowering efficacy was observed at the 1600-hour time point which approached the end of the dosing interval. PMID:22536047

  18. Pilocarpine Ophthalmic

    MedlinePlus

    Ophthalmic pilocarpine comes as a solution (liquid) to instill in the eyes and as an eye gel to apply to the eyes. The eye drops are usually ... instilling the next drop. Replace and tighten the cap on the dropper bottle. Do not wipe or ...

  19. Olopatadine Ophthalmic

    MedlinePlus

    Ophthalmic olopatadine comes as a solution (liquid) to instill in the eye. It is usually instilled in the affected eye(s) twice a day, around 6 to 8 ... instilling the next drop. Replace and tighten the cap on the dropper bottle. Do not wipe or ...

  20. Gentamicin Ophthalmic

    MedlinePlus

    Ophthalmic gentamicin comes as a solution (liquid) to instill in the eyes and as an eye ointment to apply to the eyes. The eye drops are usually ... instilling the next drop. Replace and tighten the cap on the dropper bottle. Do not wipe or ...

  1. 76 FR 71044 - Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ...), 0.004%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug... (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale for reasons of safety or effectiveness... CONTACT: Olivia J.E. Morris, Center for Drug Evaluation and Research, Food and Drug Administration,...

  2. Review of moxifloxacin hydrochloride ophthalmic solution in the treatment of bacterial eye infections

    PubMed Central

    Miller, Darlene

    2008-01-01

    Moxifloxacin hydrochloride ophthalmic solution 0.5% (Vigamox®) is the ocular formulation/adaptation of moxifloxacin. Moxifloxacin is a broad spectrum 8-methoxyfluoroquinolone which terminates bacterial growth by binding to DNA gyrase (topoisomerase II) and topoisomerase IV, essential bacterial enzymes involved in the replication, translation, repair and recombination of deoxyribonucleic acid. Affinity for both enzymes improves potency and reduces the probability of selecting resistant bacterial subpopulations. Vigamox is a bactericidal, concentration dependent, anti-infective. It is preservative free, and well tolerated with minimal ocular side effects. It provides increased penetration into ocular tissues and fluids with improved activity against Streptococci and Staphylococci species and moderate to excellent activity against clinically relevant, gram-negative ocular pathogens. PMID:19668391

  3. Comparison of Drug Concentrations in Human Aqueous Humor after the Administration of 0.3% Gatifloxacin Ophthalmic Gel, 0.3% Gatifloxacin and 0.5% Levofloxacin Ophthalmic Solutions

    PubMed Central

    Ding, Wenting; Ni, Weiling; Chen, Huilian; Yuan, Jingqun; Huang, Xiaodan; Zhang, Zheng; Wang, Yao; Yu, Yibo; Yao, Ke

    2015-01-01

    Purpose: To investigate the penetration of 0.3% gatifloxacin ophthalmic gel, 0.3% gatifloxacin ophthalmic solution and 0.5% levofloxacin ophthalmic solution into aqueous humor after topical application. Materials and Methods: Age-related cataract patients (150 eyes in 150 cases) receiving phacoemulsification were randomly divided into three groups: a 0.3% gatifloxacin gel group (n=50), a 0.3% gatifloxacin solution group (n=50), and a 0.5% levofloxacin solution group (n=50). Each group was administered one drop of gel or solution every 15 minutes for four doses. Aqueous samples were collected at different time points after the last drop. High pressure liquid chromatography (HPLC) was applied to determine the concentrations. The one-way ANOVA analysis was performed. Results: Our data indicated that the concentration of the gatifloxacin gel group was higher than that of the gatifloxacin solution group at all time points (P <0.05); moreover, the gatifloxacin gel group exhibited higher levels than the levofloxacin solution group at 120.0 min and 180.0 min (P<0.05). Furthermore, the gatifloxacin gel produced the highest concentration at 120.0 min, and the gatifloxacin and levofloxacin solutions reached their peak values at 60.0 min. Conclusions: 0.3% gatifloxacin ophthalmic gel application produced highest aqueous humor drug concentration, maintained the longest time, had the best penetration and bioavailability. PMID:26078713

  4. Clinical use of gatifloxacin ophthalmic solution for treatment of bacterial conjunctivitis

    PubMed Central

    Cervantes, Lorenzo J; Mah, Francis S

    2011-01-01

    Bacterial conjunctivitis is a common infectious disease of the eye, characterized by conjunctival hyperemia, eyelid edema, and purulent discharge. Although the prevalence and incidence are not well reported, bacterial conjunctivitis represents one of the most frequent causes of patient visits to both primary care physicians and ophthalmologists. Most cases of nongonococcal and nonchlamydial bacterial conjunctivitis are self-limiting and may resolve without intervention. There is a place for treatment, however, which allows for a shorter time to clinical and microbiological resolution which may decrease the mild morbidity, decrease health care costs of visits and potential complications, return patients back to school or the work force, and limit the potential spread of this communicable infection. Gatifloxacin ophthalmic solution is a broad spectrum 8-methoxyfluroroquinolone bactericidal antibiotic, with good activity against Staphylococcus aureus, Streptococcus species, and Gram-negative pathogens. It also has a relatively good resistance profile, making it a more than adequate choice in the treatment of bacterial conjunctivitis when therapy is warranted. PMID:21573098

  5. Poly-(cyclo)dextrins as ethoxzolamide carriers in ophthalmic solutions and in contact lenses.

    PubMed

    García-Fernández, M J; Tabary, N; Martel, B; Cazaux, F; Oliva, A; Taboada, P; Concheiro, A; Alvarez-Lorenzo, C

    2013-11-01

    Efficient ophthalmic therapy requires the development of strategies that can provide sufficiently high drug levels in the ocular structures for a prolonged time. This work focuses on the suitability of poly-(cyclo)dextrins as carriers able to solubilize the carbonic anhydrase inhibitor (CAI) ethoxzolamide (ETOX), which is so far used for oral treatment of glaucoma. Topical ocular treatment should notably enhance the efficiency/safety profile of the drug. Natural α-, β- and γ-cyclodextrins and a maltodextrin were separately polymerized using citric acid as cross-linker agent under mild conditions. The resultant hydrophilic polymers exhibited larger capability to solubilize ETOX than the pristine (cyclo)dextrins. Moreover, they provided sustained drug diffusion in artificial lachrymal fluid. Interestingly the poly-(cyclo)dextrins solutions facilitate the loading of remarkably high doses of ETOX in poly(2-hydroxyethyl methacrylate)-based contact lenses. Exploiting ionic interactions between functional groups in the contact lenses and remnant free carboxylic acids in the citric acid linkers of poly-(cyclo)dextrins led to the retention of the drug-loaded poly-(cyclo)dextrins and, in turn, to sustained release for several weeks. PMID:24053812

  6. Evaluation of atropine 1% ophthalmic solution administered sublingually for the management of terminal respiratory secretions.

    PubMed

    Protus, Bridget McCrate; Grauer, Phyllis A; Kimbrel, Jason M

    2013-06-01

    Terminal respiratory secretions (TRS) or "death rattle" is a common symptom in the dying patient. Current practice for the prevention and treatment of TRS involves the use of oral, sublingual, transdermal, or parenteral anticholinergic medications. A retrospective chart review of patients admitted to a hospice inpatient unit for terminal care and treated with sublingual atropine 1% ophthalmic drops for TRS was conducted. A total of 19 of 22 patients treated with atropine had documented reduction or resolution of TRS. This study suggests that atropine 1% ophthalmic drops administered sublingually are a reasonable option for the management of TRS. Problematic cardiac or central nervous system symptoms were not found in the present study. Results should aid hospice programs who are seeking guidance on the management of TRS with atropine 1% ophthalmic drops. PMID:22833553

  7. Safety of prophylactic intracameral moxifloxacin ophthalmic solution after cataract surgery in patients with penetrating keratoplasty

    PubMed Central

    Arslan, Osman Sevki; Arici, Ceyhun; Unal, Mustafa; Cicik, Erdogan; Mangan, Mehmet Serhat; Atalay, Eray

    2014-01-01

    AIM To determine the safety of prophylactic intracameral moxifloxacin after cataract surgery in patients with penetrating keratoplasty (PKP). METHODS In this retrospective study of consecutive patients who had phacoemulsification cataract surgery after PKP, were treated with intracameral moxifloxacin 0.5% ophthalmic solution (0.5 mg/0.1 mL). The main outcome measures were anterior chamber reaction, best corrected visual acuity (BCVA), corneal endothelial cell count (ECC), and central corneal thickness (CCT). RESULTS Fifty-five patients were recruited (26 males, 29 females). The mean age was 54.36±4.97y (range 45-64y). All eyes had improved postoperative BCVA. The mean BCVA was 0.25 preoperatively and 0.57 postoperatively, which was statistically significant (P<0.001). One eye had 3+, 7 eyes had 2+, 12 eyes had 1+ and 8 eyes had trace amount of aqueous cells on the first day after surgery. All eyes had no anterior chamber cells at subsequent follow up examinations. Effective phacoemulsification time was 4.33±1.01s. The mean ECC was 2340.20 cells/mm2 preoperatively and 1948.75 cells/mm2 1mo postoperatively (P<0.001). The increase of 21.09 µm in postoperative pachymetry 1mo after surgery was statistically significant (P<0.001). CONCLUSION No untoward effects were observed after intracameral injection of moxifloxacin (0.5 mg/0.1 mL) in terms of anterior chamber reaction, CCT, ECC, and visual rehabilitation at the conclusion of cataract surgery in patients with PKP. PMID:25349795

  8. Persistent corneal epithelial defect responding to rebamipide ophthalmic solution in a patient with diabetes

    PubMed Central

    Hayashi, Yusuke; Toshida, Hiroshi; Matsuzaki, Yusuke; Matsui, Asaki; Ohta, Toshihiko

    2016-01-01

    Objective Rebamipide ophthalmic suspension was developed for the treatment of dry eyes and for other corneal diseases, promoting the secretion of both mucin in tear fluid and membrane-associated mucin, increasing the number of goblet cells, and restoring the barrier function of the corneal epithelium. We report a case of a persistent corneal epithelial defect in a patient with diabetes treated with topical application of rebamipide ophthalmic suspension. Case presentation A 73-year-old woman had a history of type 2 diabetes for 35 years and nonproliferative diabetic retinopathy for 23 years. She presented to our department with discharge and ophthalmalgia in the left eye. A corneal ulcer was detected, and culture of corneal scrapings was performed, with Staphylococcus aureus and Streptococcus canis being isolated. The infection was treated with levofloxacin eye drops and ofloxacin ophthalmic ointment based on the sensitivity profile of the isolate. However, a corneal epithelial defect persisted for approximately 2 months despite continuing treatment with 0.1% hyaluronic acid ophthalmic suspension and 0.3% ofloxacin eye ointment. Her hemoglobin A1c was 7.3%. The persistent corneal epithelial defect showed improvement at 2 weeks after treatment with rebamipide unit dose 2% ophthalmic suspension, and it did not recur even when vitrectomy was subsequently performed for vitreous hemorrhage due to progression of diabetic retinopathy. Conclusion This is the first report about efficacy of rebamipide unit dose 2% ophthalmic suspension for presenting persistent corneal epithelial defect in a patient with diabetes. In the present case, the suggested mechanisms are the following: improving the corneal barrier function, stabilization of mucin on the keratoconjunctival epithelium, and improving the wettability and stability of the tear film, which resulted in the promotion of healing of the corneal epithelial defect in a short time period. PMID:27257394

  9. Ofloxacin Ophthalmic

    MedlinePlus

    Ophthalmic ofloxacin ophthalmic is used to treat bacterial infections of the eye, including conjunctivitis (pink eye) and ulcers of the cornea. Ofloxacin is in a class of medications called quinolone antibiotics. ...

  10. Erythromycin Ophthalmic

    MedlinePlus

    Romycin® Ophthalmic ... Ophthalmic erythromycin is used to treat bacterial infections of the eye. This medication is also used to prevent bacterial infections of the eye in newborn babies. Erythromycin is in a class ...

  11. Reduced in vivo ocular surface toxicity with polyquad-preserved travoprost versus benzalkonium-preserved travoprost or latanoprost ophthalmic solutions.

    PubMed

    Liang, Hong; Brignole-Baudouin, Françoise; Riancho, Luisa; Baudouin, Christophe

    2012-01-01

    The study used a validated acute in vivo model to compare a new formulation of travoprost 0.004% ophthalmic solution(travoprost PQ), preserved with polyquaternium-1 (PQ), with commercially available formulations of benzalkonium-chloride(BAK)-preserved travoprost 0.004% ophthalmic solution(travoprost BAK) and BAK-preserved latanoprost 0.005%ophthalmic solution (latanoprost BAK). Adult male New Zealand albino rabbits (n = 36) were randomly divided into 6 groups. Phosphate-buffered saline (PBS), 0.001% PQ, 0.015% BAK, travoprost PQ, travoprost BAK or latanoprost BAK were applied onto rabbit eyes as 1 drop, for 15 times at 5-min intervals.The ocular surface reactions were investigated at hour 4 and day 1 using slitlamp examination; in vivo confocal microscopy (IVCM) for cornea, limbus and conjunctiva/conjunctiva-associated lymphoid tissue, conjunctival impression cytology and standard immunohistology in cryosections for detecting CD45+ infiltrating cells and MUC-5AC-labeled cells. PBS, PQ and travoprost PQ did not induce obvious irritation by clinical observation, changes in microstructures of the whole ocular surface as measured by IVCM analysis,inflammatory infiltration or cell damage as measured by impression cytology, altered levels of goblet cell counts or numerous CD45+ cells in the cornea. In contrast, all BAK-containing products induced diffuse conjunctival hyperemia and chemosis, abnormal changes in the ocular surface microstructure,significant total ocular surface toxicity scores,damaged epithelial cells, inflammatory cell infiltration and decreased goblet cell density. Travoprost PQ did not elicitocular surface toxicity when administered to rabbit eyes.These results suggest a greater safety advantage for the ocular surface of patients receiving chronic glaucoma treatment with PQ-preserved drugs. PMID:22473057

  12. Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma

    PubMed Central

    Walimbe, Tejaswini; Chelerkar, Vidya; Bhagat, Purvi; Joshi, Abhijeet; Raut, Atul

    2016-01-01

    Introduction Benzalkonium chloride (BAK), included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT). BAK-containing latanoprost, an ester prodrug of prostaglandin F2α, can cause ocular adverse events (AEs) associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost. Patients and methods A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively. Results At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds) to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (P<0.0001). Ocular Surface Disease Index© (OSDI©) score also decreased significantly to 12.06±13.40 and 7.06±10.75 at 28 and 56 days, respectively, versus baseline (18.09±18.61, P<0.0001). In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, P=0.0033). A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08%) treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit lamp examinations were observed. Conclusion Results indicate that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT, OSDI© score, and inferior corneal staining score, and measurable reductions in conjunctival hyperemia score. Furthermore, BAK

  13. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial

    PubMed Central

    Goldberg, Ivan; Gil Pina, Rafael; Lanzagorta-Aresti, Aitor; Schiffman, Rhett M; Liu, Charlie; Bejanian, Marina

    2014-01-01

    Aim To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity. Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098. PMID:24667994

  14. 75 FR 54492 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution AGENCY: Food and Drug Administration, HHS...) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to... the approved conditions of use for GENTOCIN DURAFILM (gentamicin sulfate and betamethasone...

  15. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients

    PubMed Central

    Takamura, Etsuko; Tsubota, Kazuo; Watanabe, Hitoshi; Ohashi, Yuichi

    2012-01-01

    Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. Trial design and methods In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. Results After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was −0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Conclusions Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile. PMID:22914501

  16. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial

    PubMed Central

    Day, Douglas G; Walters, Thomas R; Schwartz, Gail F; Mundorf, Thomas K; Liu, Charlie; Schiffman, Rhett M; Bejanian, Marina

    2013-01-01

    Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was −0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated. Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost. PMID:23743437

  17. [A review of safety and efficacy of levofloxacin 0.5% ophthalmic solution in the treatment of external ocular infections and in prophylaxis of postoperative endophthalmitis].

    PubMed

    Lazicka-Gałecka, Monika; Gałecki, Tomasz; Szaflik, Jacek P

    2015-01-01

    Levofloxacin 0.5% ophthalmic solution is a fluoroquinolone antibacterial agent with a broad spectrum of activity against Gram positive and negative bacteria. For those reasons it is highly effective in treating common external infections of the eye including blepharitis, conjunctivitis, keratitis. In terms of microbial eradication and clinical cure rate it is significantly more effective than ofloxacin 0.3% ophthalmic solution, and non inferior to moxifloxacin ophthalmic solution. After topical administration of levofloxacin 0.5% ophthalmic solution it achieves concentration exceeding MIC90 for most clinically relevant pathogenes in tears, conjunctiva, cornea as well as anterior chamber. Thus it can be used in prophylaxis in patients undergoing ocular surgery. Because of its postantibiotic effect and high concentration in tears three times daily regimen is as effective as most frequent administration in patients with conjunctivitis, which leads to better compliance. Despite the wide use of topical and systemic levofloxacin, most common ocular pathogens remain clinically susceptible. Topical levofloxacin is well tolerated, it rarely causes systemic or ocular adverse events with the majority of treatment-related adverse effects being of mild to moderate severity. It also does not effect the wound healing. PMID:26638552

  18. Three percent diquafosol ophthalmic solution as an additional therapy to existing artificial tears with steroids for dry-eye patients with Sjögren's syndrome

    PubMed Central

    Yokoi, N; Sonomura, Y; Kato, H; Komuro, A; Kinoshita, S

    2015-01-01

    Purpose To investigate the long-term results of 3% diquafosol ophthalmic solution as an alternative therapy to existing ophthalmic solutions, including topical immunosuppression, for the treatment of dry eye in patients with Sjögren's syndrome. Methods This study involved 14 female dry-eye patients (mean age: 62.4 years) with Sjögren's syndrome who insufficiently responded to their current therapy. In all patients, 3% diquafosol ophthalmic solution was administered six times daily for 12 months in substitution for artificial tears and sodium hyaluronate ophthalmic solution. Their use of corticosteroid eye drops remained unchanged from that prior to the treatment with diquafosol sodium. The subjective symptoms assessed, and ocular signs including tear meniscus radius and the tear film breakup time, and ocular-surface epithelial damage score were examined at 1, 2, 3, 4, 5, 6, 9, and 12 months after initiating treatment. Results Among the subjective symptoms, significant improvement was obtained in dryness at 2 months post treatment, in eye fatigue at 1, 2, 3, 4, and 12 months post treatment, and in pain at 1, 2, 6, and 12 months post treatment. Difficulty in opening the eye, foreign body sensation, and redness were also significantly ameliorated at various time-points. The tear meniscus radius and the tear film breakup time were significantly improved throughout the observation period, and the corneal epithelial staining scores were significantly decreased at 3 months post treatment. Conclusions In dry-eye patients with Sjögren's syndrome, treatment with 3% diquafosol ophthalmic solution improved both symptoms and signs, and that effectiveness was maintained for 12 months. PMID:26160526

  19. Determination of antazoline and tetrahydrozoline in ophthalmic solutions by capillary electrophoresis and stability-indicating HPLC methods.

    PubMed

    Gumustas, Mehmet; Alshana, Usama; Ertas, Nusret; Goger, Nilgun Gunden; Ozkan, Sibel A; Uslu, Bengi

    2016-05-30

    Capillary electrophoretic (CE) and high performance liquid chromatographic (HPLC) methods were developed and optimized for the determination of antazoline (ANT) and tetrahydrozoline (TET) in ophthalmic formulations. Optimum electrophoretic conditions were achieved using a background electrolyte of 20mM phosphate buffer at pH 7.0, a capillary temperature of 25°C, a separation voltage of 22kV and a pressure injection of the sample at 50mbar for 17s. HPLC analysis was performed with Kinetex (150×4.6mm ID×5μm) (Phenomenex, USA) analytical column with 1mLmin(-1) flow rate of mobile phase which consisted of 0.05% TFA in bidistilled water (pH adjusted to 3.0 with 5M NaOH) and acetonitrile/buffer in the ratio of 63:37 (v/v) at room temperature. Injection volume of the samples was 10μL and the wavelength of the detector was set at 215nm for monitoring both analytes. Calibration graphs showed a good linearity with a coefficient of determination (R(2)) of at least 0.998 for both methods. Intraday and interday precision (expressed as RSD%) were lower than 2.8% for CE and 0.92% for HPLC. The developed methods were demonstrated to be simple and rapid for the determination of ANT and TET in ophthalmic solutions providing recoveries in the range between 97.9 and 102.70% for CE and HPLC. PMID:26952922

  20. Bromfenac Ophthalmic

    MedlinePlus

    ... redness (inflammation) and pain that can occur after cataract surgery. Bromfenac ophthalmic is in a class of ... eye(s) once a day beginning one day before cataract surgery, on the day of the surgery, and ...

  1. Ciprofloxacin Ophthalmic

    MedlinePlus

    ... to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of the membrane that covers the outside ... eye). Ciprofloxacin ophthalmic ointment is used to treat conjunctivitis. Ciprofloxacin is in a class of antibiotics called ...

  2. Besifloxacin Ophthalmic

    MedlinePlus

    Besifloxacin ophthalmic is used to treat bacterial conjunctivitis (pinkeye; infection of the membrane that covers the outside of the eyeballs and the inside of the eyelids). Besifloxacin is in a class ...

  3. Cyclosporine Ophthalmic

    MedlinePlus

    Ophthalmic cyclosporine is used to increase tear production in people with dry eye disease. Cyclosporine is in a class of medications called immunomodulators. It works by decreasing swelling in the eye ...

  4. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study

    PubMed Central

    Karpecki, Paul M.; Majmudar, Parag A.; Nichols, Kelly K.; Raychaudhuri, Aparna; Roy, Monica; Semba, Charles P.

    2016-01-01

    Purpose: To evaluate the 1-year safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease compared with placebo. Methods: SONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution) was a multicenter, randomized, prospective, double-masked, placebo-controlled phase 3 study (NCT01636206). Adults (≥18 years) with dry eye disease (Schirmer test score ≥1 and ≤10 mm; corneal staining score ≥2.0) were randomized 2:1 to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 360 days. The primary objective was percentage and severity of treatment-emergent adverse events (TEAEs). Secondary objectives were ocular safety measures: corneal fluorescein staining, drop comfort, best-corrected visual acuity, slit-lamp biomicroscopy, and intraocular pressure over 7 visits. Exploratory objectives included concentration of lifitegrast in plasma. Results: The safety population comprised 331 participants (220 lifitegrast; 111 placebo). There were no serious ocular TEAEs. Overall, 53.6% of participants receiving lifitegrast experienced ≥1 ocular TEAE versus 34.2% in the placebo group; most TEAEs were mild to moderate in severity. Rates of discontinuation because of TEAEs were 12.3% (lifitegrast) versus 9.0% (placebo). The most common (>5%) TEAEs occurring in either treatment group were instillation site irritation (burning), instillation site reaction, visual acuity reduced, dry eye, and dysgeusia (change in taste). Ocular safety parameters for lifitegrast were similar to placebo. The mean plasma lifitegrast concentration at 360 days (n = 43) was below the limit of detection. There was no indication of systemic toxicity or localized infectious complications secondary to chronic immunosuppression. Conclusions: Lifitegrast ophthalmic solution 5.0% seemed safe and well tolerated in this study, with no unexpected adverse events. PMID:27055211

  5. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee; Notice... be open to the public. Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee...) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by...

  6. Polyvinyl pyrrolidone capped fluorescent anthracene nanoparticles for sensing fluorescein sodium in aqueous solution and analytical application for ophthalmic samples.

    PubMed

    Bhopate, Dhanaji P; Mahajan, Prasad G; Garadkar, Kalyanrao M; Kolekar, Govind B; Patil, Shivajirao R

    2015-11-01

    Based on the known complexation ability between polyvinyl pyrrolidone (PVP) and fluorescein sodium (FL Na(+)), fluorescent PVP capped anthracene nanoparticles (PVP-ANPs) were prepared using a reprecipitation method for detection of fluorescein in aqueous solution using the fluorescence resonance energy transfer (FRET) approach. A dynamic light scattering histogram of PVP-ANPs showed narrower particle size distribution and the average particle size was 15 nm. The aggregation-induced enhanced emission (AIEE) of PVP-ANPs was red shifted from its monomer by 1087.22 cm(-1). The maximum emission was seen to occur at 420 nm. The presence of FL Na(+) in the vicinity of PVP-ANPs quenched the fluorescence of PVP-ANPs because of its adsorption on the surface of PVP-ANPs in aqueous suspension. The FL Na(+) and PVP-ANPs were brought close enough, typically to 7.89 nm, which was less than the distance of 10 nm that is required between the energy donor-acceptor molecule for efficient FRET. The quenching results fit into the Stern-Volmer relationship even at temperatures greater than ambient temperatures. The thermodynamic parameters determined from FRET results helped to propose binding mechanisms involving hydrophobic and electrostatic molecular interaction. The fluorescence quenching results were used further to develop an analytical method for estimation of fluorescein sodium from ophthalmic samples available commercially in the market. PMID:25736374

  7. Stability-Indicating HPLC Method for Simultaneous Determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in Ophthalmic Solution

    PubMed Central

    AlAani, Hashem; Alnukkary, Yasmin

    2016-01-01

    Purpose: A simple stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in ophthalmic solution in the presence of 2-amino-1-(4-nitrophenyl)propane-1,3-diol, a degradation product of Chloramphenicol, and Dexamethasone, a degradation product of Dexamethasone Sodium Phosphate. Methods: Effective chromatographic separation was achieved using C18 column (250 mm, 4.6 mm i.d., 5 μm) with isocratic mobile phase consisting of acetonitrile - phosphate buffer (pH 4.0; 0.05 M) (30:70, v/v) at a flow rate of 1 mL/minute. The column temperature was maintained at 40°C and the detection wavelength was 230 nm. Results: The proposed HPLC procedure was statistically validated according to the ICH guideline, and was proved to be stability-indicating by resolution of the APIs from their forced degradation products. Conclusion: The developed method is suitable for the routine analysis as well as stability studies. PMID:27123429

  8. 75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... parasites that were approved for the pioneer product with 3 years of marketing exclusivity (69 FR 501... external and internal parasites when cattle are treated with a topical solution of ivermectin. DATES: This... solution used on cattle to control infestations of certain species of external and internal parasites....

  9. Latanoprost Ophthalmic

    MedlinePlus

    Latanoprost ophthalmic is used to treat glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) and ... a condition which causes increased pressure in the eye). Latanoprost is in a class of medications called ...

  10. 76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... exclusivity (69 FR 501, January 6, 2004). The supplemental ANADA is approved as of September 21, 2011, and 21... supplemental ANADA adds claims for persistent effectiveness against various species of external and internal... topical solution used on cattle to control infestations of certain species of external and...

  11. Comparison of effect of nepafenac and diclofenac ophthalmic solutions on cornea, tear film, and ocular surface after cataract surgery: the results of a randomized trial

    PubMed Central

    Kawahara, Atsushi; Utsunomiya, Tsugiaki; Kato, Yuji; Takayanagi, Yoshinori

    2016-01-01

    Background The aim of this study was to compare the effects of nepafenac ophthalmic suspension 0.1% (Nevanac) and diclofenac sodium ophthalmic solution 0.1% (Diclod) on the cornea, tear film, and ocular surface after cataract surgery. Methods A total of 60 eyes (60 patients) were selected for this study, with no ocular diseases other than cataract (scheduled for cataract surgery by one surgeon). Patients were randomly enrolled to receive nepafenac or diclofenac in the perioperative period, and cataract surgery was performed using torsional microcoaxial phacoemulsification and aspiration with intraocular lens implantation via a transconjunctival single-plane sclerocorneal incision at the 12 o’clock position. We compared intra- and intergroup differences preoperatively and postoperatively in conjunctival and corneal fluorescein staining scores, tear film breakup times, Schirmer’s tests, the Dry Eye Related Quality of Life Scores, and tear meniscus areas using anterior segment optical coherence tomography. Results The diclofenac group had significantly higher conjunctival and corneal fluorescein staining scores at 4 weeks postoperatively compared with the nepafenac group (P<0.001). Within the diclofenac group, significantly higher conjunctival and corneal fluorescein staining scores were noted at 4 weeks postoperatively than those seen preoperatively (P<0.001) and at 1 week postoperatively (P<0.001). No statistically significant differences were found in any other items. Conclusions Nepafenac ophthalmic suspension 0.1% is considered safe for the corneal epithelium after cataract surgery. PMID:27019091

  12. Evaluation of corneal optical properties in subjects wearing hydrogel etafilcon A contact lenses and the effect of administering mannitol-enriched sodium hyaluronate ophthalmic solution

    PubMed Central

    Lombardo, Marco; Rosati, Marianna; Pileri, Marco; Schiano-Lomoriello, Domenico; Serrao, Sebastiano

    2014-01-01

    Background The purpose of this study was to evaluate the effect of daily administration of mannitol-enriched sodium hyaluronate ophthalmic solution on the corneal optical properties of subjects wearing low Dk hydrogel (etafilcon A) contact lenses (CLs). Methods Forty-five subjects wearing etafilcon A CLs daily for more than 6 months were recruited into this pilot study. Fifteen of the subjects administered a 10% mannitol-enriched 0.05% sodium hyaluronate solution (study group) once daily and 30 subjects did not administer any ophthalmic solution (control group). The subjects were examined at baseline and one month after recruitment. Changes in central corneal thickness (CCT) and corneal light backscatter were evaluated by Scheimpflug imaging (Pentacam HR). Changes in corneal total high-order aberration, corneal spherical aberration, coma, and trefoil were evaluated using the OPD scan II. Results At one month, corneal light backscatter decreased significantly in the study group (≤18.30 arbitrary units; P<0.05) and this was highly correlated with a decrease in CCT (R=0.81; P=0.04). The decrease in corneal total high-order aberration, spherical aberration, and coma was significantly higher in the study group than in the control group (P<0.05). No changes in corneal light backscatter or CCT were found in the control group during follow-up. Conclusion Once-daily administration of a mannitol-enriched lubricant ophthalmic solution was effective for improving the corneal optical quality and reducing corneal swelling in subjects wearing low Dk hydrogel (etafilcon A) CLs during one month follow-up. PMID:25473260

  13. Concentrations of nandrolone metabolites in urine after the therapeutic administration of an ophthalmic solution.

    PubMed

    Avois, Lidia; Mangin, Patrice; Saugy, Martial

    2007-05-01

    Nandrolone, an anabolic steroid, is used for the treatment of several diseases and is available in various pharmaceutical formulations. The most widely used pharmaceutical formulation is Deca-Durabolin, but other products, such as Keratyl eye drops solution, are also currently administered. Nandrolone is one of the most abused anabolic steroid in sports. Analyses for this anabolic steroid according to the World Anti-Doping Agency (WADA) protocol are based on the identification of the nandrolone two main urinary metabolites which, in humans, are glucuronides of 19-norandrosterone and 19-noretiocholanolone. A positive cut off limit of 2 ng/mL has been set by the anti-doping code for the first metabolite, 19-norandrosterone. In this preliminary study, an eye drops solution (Keratyl) containing a therapeutic dose of a nandrolone sodium sulphate was administered to several male volunteers during 3 days and urines were collected during 3 weeks. Surprisingly, contrary to all expectations, the urinary concentrations measured in urines reached 450 ng/mL and 70 ng/mL for norandrosterone and noretiocholanolone, respectively. Moreover, concentration levels near to 2 ng/mL were found, more than 2 weeks after the last administration, depending on individual metabolism. Inter-variability as well as intra-variability of nandrolone excretion kinetic, regarding this particular administration mode, were also evaluated. Quantification of nandrolone metabolites was performed by GC-MS. The method was previously validated in terms of specificity, precision, linearity, LOD, LOQ, robustness, accuracy and the expanded uncertainty was also evaluated. PMID:17391892

  14. Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%

    PubMed Central

    Greiner, Jack V; Edwards-Swanson, Kimberly; Ingerman, Avner

    2011-01-01

    Purpose To evaluate the effectiveness of alcaftadine 0.05%, 0.1%, and 0.25% ophthalmic solutions in treating the signs and symptoms of allergic conjunctivitis when compared with olopatadine hydrochloride 0.1% and placebo using the conjunctival allergen challenge (CAC) model. Methods One hundred and seventy subjects were randomized and 164 subjects completed all visits. CAC was performed to determine and confirm subjects’ eligibility at visits 1 and 2, respectively. The CAC was repeated at visit 3 (day 0 ± 3), 16 hours after study medication instillation, and at visit 4 (day 14 ± 3), 15 minutes after instillation. Ocular itching and conjunctival redness were evaluated after an allergen challenge, along with several secondary endpoints. Results Alcaftadine 0.25% and olopatadine 0.1% treatments exhibited significantly lower mean scores compared with placebo for ocular itching and conjunctival redness at visits 3 and 4. Most adverse events were self-limiting and mild in severity. No serious treatment-related adverse events occurred. Conclusion Treatment with alcaftadine 0.25% ophthalmic solution resulted in mean differences of >1 unit (ocular itching) and approximately >1 unit (conjunctival redness), which was significant (P < 0.001) compared with placebo treatment. All doses of alcaftadine were safe and well tolerated in the population studied. PMID:21339800

  15. The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

    PubMed Central

    Silverstein, Steven M; Jackson, Mitchell A; Goldberg, Damien F; Muñoz, Mauricio

    2014-01-01

    Purpose To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation. Methods The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day –1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores). Results The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). Conclusion Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and

  16. Update and critical appraisal of the use of topical azithromycin ophthalmic 1% (AzaSite®) solution in the treatment of ocular infections

    PubMed Central

    Utine, Canan Asli

    2011-01-01

    Azithromycin is an azalide that acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. Azithromycin is also noted by anti-inflammatory and immunomodulatory activity. AzaSite® (Inspire Pharmaceuticals, Inc, Durham, NC) is azithromycin ophthalmic solution, 1% formulated in polycarbophil (the aqueous mucoadhesive polymer contained in DuraSite®) that delivers high and prolonged azithromycin concentrations in a variety of ocular tissues, including the conjunctiva, cornea and particularly the eyelid. AzaSite was approved by the Food and Drug Administration (FDA) in the US in 2007, for the treatment of bacterial conjunctivitis caused by susceptible isolates. This article aims to evaluate the peer-reviewed published scientific literature and to define well-established uses of AzaSite eye drops in the field of ocular infections. PMID:21750614

  17. Ophthalmic thermal injuries.

    PubMed

    Lipshy, K A; Wheeler, W E; Denning, D E

    1996-06-01

    Reflex lid closure often protects the eyes during facial burns. Although corneal burns are uncommon, other ophthalmic injuries occur more frequently. Ophthalmic burns are usually associated with marked facial damage and possible inhalation injury. Failure to recognize and appropriately treat ophthalmic burns can lead to catastrophic sequelae. We performed a 2-year survey of all facial burns in our burn unit. Forty-four patients with thermal facial burns were identified. Sixteen patients had ophthalmic injuries. Corneal injury was detected in 13 per cent (2/16). Intubation was required in 43.75 per cent (7/16) of patients with ophthalmic injuries. Mortality was 25 per cent (4/16). We conclude that patients with facial burns severe enough to cause ophthalmic injuries may be associated with other lethal injuries, and a high index of suspicion should be maintained until all lethal injuries are ruled out. All ophthalmic injuries should be evaluated by an ophthalmologist. PMID:8651533

  18. Ophthalmic halo reduced lenses design

    NASA Astrophysics Data System (ADS)

    Limon, Ofer; Zalevsky, Zeev

    2015-05-01

    The halo effect is a very problematic visual artifact occurring in extended depth of focus or multi-focal ophthalmic lenses such as e.g. intra-ocular (after cataract surgery) or contact lenses when used in dark illumination conditions. This artifact is generated due to surface structures added on top of those lenses in order to increase their depth of focus or to realize multiple focal lengths. In this paper we present novel solution that can resolve this major problem of ophthalmic lenses. The proposed solution involves modification to the surface structure that realizes the extended depth of focus. Our solution is fabricated and numerically and experimentally validated also in preliminary in-vivo trials.

  19. Dexamethasone Ophthalmic

    MedlinePlus

    ... It is not necessary to shake dexamethasone eyedrop solution.To use the eyedrops, follow these instructions: Wash ... instilling the next drop. Replace and tighten the cap on the dropper bottle. Do not wipe or ...

  20. Timolol Ophthalmic

    MedlinePlus

    ... gel when instilled in the eye). Timolol eye drops are usuallyinstilled once or twice a day, at ... often than prescribed by your doctor.Timolol eye drops and gel-forming solution control glaucoma but do ...

  1. A comparative study of validated spectrophotometric and TLC- spectrodensitometric methods for the determination of sodium cromoglicate and fluorometholone in ophthalmic solution.

    PubMed

    Saleh, Sarah S; Lotfy, Hayam M; Hassan, Nagiba Y; Elgizawy, Samia M

    2013-10-01

    The determination of sodium cromoglicate (SCG) and fluorometholone (FLU) in ophthalmic solution was developed by simple, sensitive and precise methods. Three spectrophotometric methods were applied: absorptivity factor (a-Factor method), absorption factor (AFM) and mean centering of ratio spectra (MCR). The linearity ranges of SCG were found to be (2.5-35 μg/mL) for (a-Factor method) and (MCR); while for (AFM), it was found to be (7.5-50 μg/mL). The linearity ranges of FLU were found to be (4-16 μg/mL) for (a-Factor method) and (AFM); while for (MCR), it was found to be (2-16 μg/mL). The mean percentage recoveries/RSD for SCG were found to be 100.31/0.90, 100.23/0.57 and 100.43/1.21; while for FLU, they were found to be 100.11/0.56, 99.97/0.35 and 99.94/0.88 using (a-Factor method), (AFM) and (MCR), respectively. A TLC-spectrodensitometric method was developed by separation of SCG and FLU on silica gel 60 F254 using chloroform:methanol:toluene:triethylamine in the ratio of (5:2:4:1 v/v/v/v) as developing system, followed by spectrodensitometric measurement of the bands at 241 nm. The linearity ranges and the mean percentage recoveries/RSD were found to be (0.4-4.4 μg/band), 100.24/1.44 and (0.2-1.6 μg/band), 99.95/1.50 for SCG and FLU, respectively. A comparative study was conducted between the proposed methods to discuss the advantage of each method. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution in the presence of benzalkonium chloride as a preservative. These methods could be an alternative to different HPLC techniques in quality control laboratories lacking the required facilities for those expensive techniques. PMID:24227962

  2. A comparative study of validated spectrophotometric and TLC- spectrodensitometric methods for the determination of sodium cromoglicate and fluorometholone in ophthalmic solution

    PubMed Central

    Saleh, Sarah S.; Lotfy, Hayam M.; Hassan, Nagiba Y.; Elgizawy, Samia M.

    2013-01-01

    The determination of sodium cromoglicate (SCG) and fluorometholone (FLU) in ophthalmic solution was developed by simple, sensitive and precise methods. Three spectrophotometric methods were applied: absorptivity factor (a-Factor method), absorption factor (AFM) and mean centering of ratio spectra (MCR). The linearity ranges of SCG were found to be (2.5–35 μg/mL) for (a-Factor method) and (MCR); while for (AFM), it was found to be (7.5–50 μg/mL). The linearity ranges of FLU were found to be (4–16 μg/mL) for (a-Factor method) and (AFM); while for (MCR), it was found to be (2–16 μg/mL). The mean percentage recoveries/RSD for SCG were found to be 100.31/0.90, 100.23/0.57 and 100.43/1.21; while for FLU, they were found to be 100.11/0.56, 99.97/0.35 and 99.94/0.88 using (a-Factor method), (AFM) and (MCR), respectively. A TLC-spectrodensitometric method was developed by separation of SCG and FLU on silica gel 60 F254 using chloroform:methanol:toluene:triethylamine in the ratio of (5:2:4:1 v/v/v/v) as developing system, followed by spectrodensitometric measurement of the bands at 241 nm. The linearity ranges and the mean percentage recoveries/RSD were found to be (0.4–4.4 μg/band), 100.24/1.44 and (0.2–1.6 μg/band), 99.95/1.50 for SCG and FLU, respectively. A comparative study was conducted between the proposed methods to discuss the advantage of each method. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution in the presence of benzalkonium chloride as a preservative. These methods could be an alternative to different HPLC techniques in quality control laboratories lacking the required facilities for those expensive techniques. PMID:24227962

  3. Utility of Experimental Design in Pre-Column Derivatization for the Analysis of Tobramycin by HPLC—Fluorescence Detection: Application to Ophthalmic Solution and Human Plasma

    PubMed Central

    El-Zaher, Asmaa A.; Mahrouse, Marianne A.

    2013-01-01

    A novel, selective, and sensitive reversed phase high-performance liquid chromatography (HPLC) method coupled with fluorescence detection has been developed for the determination of tobramycin (TOB) in pure form, in ophthalmic solution and in spiked human plasma. Since TOB lacks UV absorbing chromophores and native fluorescence, pre-column derivatization of TOB was carried out using fluorescamine reagent (0.01%, 1.5 mL) and borate buffer (pH 8.5, 2 mL). Experimental design was applied for optimization of the derivatization step. The resulting highly fluorescent stable derivative was chromatographed on C18 column and eluted using methanol:water (60:40, v/v) at a flow rate of 1 mL min−1. A fluorescence detector (λex 390 and λem 480 nm) was used. The method was linear over the concentration range 20–200 ng mL−1. The structure of the fluorescent product was proposed, the method was then validated and applied for the determination of TOB in human plasma. The results were statistically compared with the reference method, revealing no significant difference. PMID:23700362

  4. Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

    PubMed Central

    Wirta, David; VanDenburgh, Amanda M; Weng, Emily; Whitcup, Scott M; Kurstjens, Sef; Beddingfield, Frederick C

    2011-01-01

    Background: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP) based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥12 months) were conducted; however, the aggregate safety profile of the six studies has not been reported. Methods: Adverse events (AEs) were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD) or twice daily (BID) as an eyedrop. AE terms were converted to MedDRA (V.11.0) Preferred Terms and analyzed. Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD) and 94.8% (BID) of subjects (≤12 months of treatment). AEs reported through month 12 (aggregate incidence of ≥5%) were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment. Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation. PMID:21691584

  5. Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients

    PubMed Central

    Miyake, Hideki; Kawano, Yuri; Tanaka, Hiroshi; Iwata, Akihiro; Imanaka, Takahiro; Nakamura, Masatsugu

    2016-01-01

    Purpose We aimed to evaluate the feasibility of using a modified Schirmer test to determine the increase in tear volume after administration of 3% diquafosol ophthalmic solution (diquafosol 3%) in dry eye patients. Patients and methods A randomized, multicenter, prospective, double-blind clinical study recruited 50 qualified subjects. They received diquafosol 3% in one eye and artificial tears in the other eye. The study protocol comprised a screening and treatment procedure completed within 1 day. The Schirmer test was performed on closed eyes three times a day. The primary efficacy end points were the second Schirmer test scores 10 minutes after the single dose. Secondary end points were the third Schirmer test scores 3 hours and 40 minutes after the single dose and the symptom scores prior to the second and third Schirmer tests. Results According to the Schirmer test, 10 minutes after administration, diquafosol 3% significantly increased tear volume compared to artificial tears. Diquafosol 3% and artificial tears both showed significant improvements in the symptom scores compared to baseline. However, there was no significant difference in the symptoms score between diquafosol 3% and artificial tears. Conclusion The modified Schirmer test can detect a minute change in tear volume in dry eye patients. These findings will be useful in the diagnosis of dry eye, assessment of treatment benefits in daily clinical practice, and the development of possible tear-secreting compounds for dry eye. PMID:27257372

  6. Computation of Dioptric and Magnification Matrices in Ophthalmic Lenses

    NASA Astrophysics Data System (ADS)

    Barbero, S.

    2014-06-01

    The diopter power and magnification matrices characterize the first-order properties of ophthalmic lenses for different gaze directions. Therefore an efficient method to compute them is highly valuable in ophthalmic lens design and optical performance simulations. I present a novel method to numerically compute these matrices in ophthalmic lenses comprising any set of arbitrary surfaces. The method is based on computing one base ray, along the gaze direction, and two rays close to it. These two rays are obtained varying a small parameter that indicates their separation from the base ray. The method was validated comparing the results with a single refractive surface where exact solutions are directly obtained.

  7. Semisolid ophthalmic vehicles.

    PubMed

    Giannaccini, B; Alderigi, C

    1989-09-01

    The present review is concerned with some essential formulative and therapeutic aspects of semisolid ophthalmic vehicles. The history and the most recent developments of the traditional lipophilic vehicles (ointments) are first outlined. The hydrophilic vehicles (hydrogels) based on synthetic polymers (polyacrylates, PEG, PVA, Pluronics, etc.), semisynthetic polymers (cellulose derivatives) and natural polymers (hyaluronic and polygalacturonic acid, alginates, etc.) are then examined. Some recent formulations of particular type are finally described. PMID:2699716

  8. Metabolic Acidosis with Ophthalmic Dorzolamide in a Neonate

    PubMed Central

    Capino, Amanda C.; Dannaway, Douglas C.

    2016-01-01

    Carbonic anhydrase inhibitors are a common cause of normal anion gap metabolic acidosis; however, development is less commonly associated with ophthalmic administration of these agents. We report a case of a premature neonate who was being treated at our institution with betaxolol, dorzolamide, and latanoprost ophthalmic products for suspected bilateral congenital glaucoma. In addition, the patient was also receiving caffeine, ursodiol, and acidified liquid human milk fortifier. The patient developed a normal anion gap metabolic acidosis, and both dorzolamide ophthalmic solution and the acidified human milk fortifier were considered potential causes. Upon discontinuation of the dorzolamide ophthalmic solution and the switching of liquid human milk fortifiers, the normal anion gap metabolic acidosis gradually resolved. As a result of the pH and acidity, the acidified liquid human milk fortifier is thought to be associated with an anion gap acidosis; therefore, dorzolamide is suspected to be the primary cause of a normal gap acidosis. This case demonstrates that systemic effects can occur with ophthalmic administration of dorzolamide in a premature neonate. Ophthalmic agents should not be overlooked as a potential cause of systemic toxicity. PMID:27453705

  9. Metabolic Acidosis with Ophthalmic Dorzolamide in a Neonate.

    PubMed

    Capino, Amanda C; Dannaway, Douglas C; Miller, Jamie L

    2016-01-01

    Carbonic anhydrase inhibitors are a common cause of normal anion gap metabolic acidosis; however, development is less commonly associated with ophthalmic administration of these agents. We report a case of a premature neonate who was being treated at our institution with betaxolol, dorzolamide, and latanoprost ophthalmic products for suspected bilateral congenital glaucoma. In addition, the patient was also receiving caffeine, ursodiol, and acidified liquid human milk fortifier. The patient developed a normal anion gap metabolic acidosis, and both dorzolamide ophthalmic solution and the acidified human milk fortifier were considered potential causes. Upon discontinuation of the dorzolamide ophthalmic solution and the switching of liquid human milk fortifiers, the normal anion gap metabolic acidosis gradually resolved. As a result of the pH and acidity, the acidified liquid human milk fortifier is thought to be associated with an anion gap acidosis; therefore, dorzolamide is suspected to be the primary cause of a normal gap acidosis. This case demonstrates that systemic effects can occur with ophthalmic administration of dorzolamide in a premature neonate. Ophthalmic agents should not be overlooked as a potential cause of systemic toxicity. PMID:27453705

  10. 21 CFR 886.1120 - Ophthalmic camera.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic camera. 886.1120 Section 886.1120 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1120 Ophthalmic camera. (a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding...

  11. 21 CFR 886.1120 - Ophthalmic camera.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic camera. 886.1120 Section 886.1120 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1120 Ophthalmic camera. (a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding...

  12. 21 CFR 886.4390 - Ophthalmic laser.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding...

  13. 21 CFR 886.4390 - Ophthalmic laser.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding...

  14. 21 CFR 886.4390 - Ophthalmic laser.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding...

  15. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze,...

  16. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze,...

  17. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze,...

  18. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze,...

  19. 21 CFR 886.4790 - Ophthalmic sponge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze,...

  20. 21 CFR 886.1760 - Ophthalmic refractometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic refractometer. 886.1760 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1760 Ophthalmic refractometer. (a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation...

  1. 21 CFR 886.4690 - Ophthalmic photocoagulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic photocoagulator. 886.4690 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4690 Ophthalmic photocoagulator. (a) Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an...

  2. 21 CFR 886.3130 - Ophthalmic conformer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic conformer. 886.3130 Section 886.3130...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3130 Ophthalmic conformer. (a) Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be...

  3. 21 CFR 886.1680 - Ophthalmic projector.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic projector. 886.1680 Section 886.1680...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1680 Ophthalmic projector. (a) Identification. An ophthalmic projector is an AC-powered device intended to project an image on a screen for...

  4. 21 CFR 886.1140 - Ophthalmic chair.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic chair. 886.1140 Section 886.1140 Food... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1140 Ophthalmic chair. (a) Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to...

  5. 21 CFR 886.4390 - Ophthalmic laser.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding...

  6. 21 CFR 886.4390 - Ophthalmic laser.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding...

  7. Patent perspectives for corticosteroids based ophthalmic therapeutics.

    PubMed

    Suresh, Preeti K; Sah, Abhishek K

    2014-01-01

    Eye inflammation, if untreated at right time poses the risk of vision loss. Several categories of drugs are available in the global market, but corticosteroids are still used for the treatment of ocular inflammation including anterior/ posterior uveitis, age related macular degeneration (AMD) and post cataract surgery inflammation. Although corticosteroids have well-documented side effects as compared to non steroidal anti-inflammatory drugs (NSAIDs), but they are still regarded as better anti-inflammatory agents for treating ocular inflammations. The prime concern with conventional formulations such as (ophthalmic solutions, suspensions, ointments) is low drug bioavailability due to precorneal barrier of the eye, tear turnover and rapid drainage of drug via nasolacrimal drainage and drug induced systemic toxicity. To overcome these limitations, various novel formulations of corticosteroids have been explored. These include nanoparticles, solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC), nanomicelles, in-situ gels, iontophoresis, liposomes, nanoemulsions, microemulsions and ocular implants for the effective ophthalmic delivery of the corticosteroids. Topical nanocarriers have also been demonstrated to be promising vectors with potential application in the ophthalmic therapeutics. This review summarizes the clinical findings and patents on various corticosteroids as ocular pharmacotherapeutics. PMID:25020063

  8. Ophthalmic manifestations postlightning strike.

    PubMed

    Dhillon, Permesh Singh; Gupta, Mohit

    2015-01-01

    Various ophthalmic complications affecting the anterior and posterior segments have been identified due to lightning strike. We report the first case of an indirect lightning-induced full thickness macular hole formation in the UK as evidenced by slit lamp examination and optical coherence tomography (OCT) scan in a 77-year-old woman presenting with sudden visual loss in her right eye and thermal skin injury affecting her scalp. Her best corrected visual acuities were LogMAR 0.46 and 0.12 in the right and left eyes, respectively. There were no other ocular manifestations observed in either eye. She was initially managed conservatively with non-steroidal anti-inflammatory drug eye drops but surgery was later advised due to minimal changes in the visual acuity and macular hole on follow-up. OCT scanning is important in diagnosing macular holes, which usually warrant surgical intervention. PMID:25827914

  9. Ophthalmic timolol: plasma concentration and systemic cardiopulmonary effects.

    PubMed

    Nieminen, T; Lehtimäki, T; Mäenpää, J; Ropo, A; Uusitalo, H; Kähönen, M

    2007-01-01

    Timolol maleate is a non-selective beta-adrenoceptor antagonist currently used mainly as an ocular preparation for the treatment of glaucoma and ocular hypertension. Despite the topical administration, ophthalmic timolol causes systemic adrenergic beta-blocking because of absorption from the eye into the systemic circulation. Gel formulations of ophthalmic timolol have been developed to reduce systemic absorption and adverse effects in comparison with conventional aqueous solution formulations. Timolol is metabolized by the polymorphic cytochrome P450 2D6 enzyme (CYP2D6). The changes in heart rate (HR) are the most striking effects of the systematically absorbed fraction of ophthalmic timolol, with 0.5 % aqueous formulations presenting larger effects than 0.1 % hydrogel formulations, especially during exercise. Plasma levels of ophthalmic timolol correlate with the changes in HR. Neither 0.5 % aqueous nor 0.1 % hydrogel formulations of timolol have exerted noteworthy effects on systolic (SAP) or diastolic (DAP) arterial pressures, probably because of a compensatory increase in systemic vascular resistance due to the attenuation of HR. Ophthalmic timolol does not exert remarkable effects on pulmonary parameter peak expiratory flow (PEF) and forced expiratory volume in 1 s (FEV1) in non-asthmatic patients. CYP2D6 activity is clearly associated with the pharmacokinetic parameters, particularly when 0.5 % aqueous solution of timolol is used: peak plasma concentration, elimination half-life and area-under-the-curve are highest in CYP2D6 poor metabolizers. Finally, since there is a correlation between the plasma level of timolol and several haemodynamic effects - especially HR in the state of elevated beta-adrenergic tonus - the CYP2D6 poor metabolizers may be more prone to bradycardia during treatment with (aqueous) ophthalmic timolol. PMID:17366003

  10. 21 CFR 349.12 - Ophthalmic demulcents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Ophthalmic demulcents. 349.12 Section 349.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.12 Ophthalmic demulcents. The active ingredients of...

  11. Patient adherence and persistence with topical ocular hypotensive therapy in real-world practice: a comparison of bimatoprost 0.01% and travoprost Z 0.004% ophthalmic solutions

    PubMed Central

    Campbell, Joanna H; Schwartz, Gail F; LaBounty, Britni; Kowalski, Jonathan W; Patel, Vaishali D

    2014-01-01

    Background Effective control of intraocular pressure is predicated upon patient compliance with pharmacotherapy. We compared patient adherence and persistence with two new ocular hypotensive formulations, using real-world utilization data. Methods This observational cohort study employed pharmacy claims data from the Source® Lx (Wolters Kluwer Pharma Solutions) database. Patients with an initial (index) prescription for topical bimatoprost 0.01% or travoprost Z (April to June 2011) and no claim for ophthalmic prostaglandin or prostamide analogs within the previous 18 months were identified. Treatment adherence was expressed as proportion of days covered with study medication during the first 365 days after the index prescription. Treatment persistence with study medication was assessed over the first 12 months using Kaplan–Meier survival analyses, allowing a maximum 30-day gap for prescription refill. Treatment status was determined monthly over this period. Results A total of 12,985 patients were assessed for treatment adherence, and 10,470 for treatment persistence. Adherence was better with bimatoprost 0.01% than with travoprost Z (mean proportion of days covered 0.540 versus [vs] 0.486, P<0.001), and more patients showed high adherence (proportion of days covered >0.80) with bimatoprost 0.01% than travoprost Z (29.1% vs 22.3%, P<0.001). Continuous 12-month persistence was higher with bimatoprost 0.01% than with travoprost Z (29.5% vs 24.2%, P<0.001). At month 12, more patients were on treatment with bimatoprost 0.01% than travoprost Z (48.8% vs 45.7%, P<0.01). Similar findings were demonstrated in cohorts of ocular hypotensive treatment-naïve patients, branded latanoprost switchers, and older patients (age ≥65 years), and after inclusion of patient characteristics as covariates. Conclusion For patients with glaucoma or ocular hypertension, bimatoprost 0.01% offers compliance advantages over travoprost Z. PMID:24868144

  12. Ophthalmic Disorders in Adults with Down Syndrome

    PubMed Central

    Krinsky-McHale, Sharon J.; Jenkins, Edmund C.; Zigman, Warren B.; Silverman, Wayne

    2012-01-01

    A myriad of ophthalmic disorders is associated with the phenotype of Down syndrome including strabismus, cataracts, and refractive errors potentially resulting in significant visual impairment. Ophthalmic sequelae have been extensively studied in children and adolescents with Down syndrome but less often in older adults. In-depth review of medical records of older adults with Down syndrome indicated that ophthalmic disorders were common. Cataracts were the most frequent ophthalmic disorder reported, followed by refractive errors, strabismus, and presbyopia. Severity of intellectual disability was unrelated to the presence of ophthalmic disorders. Also, ophthalmic disorders were associated with lower vision-dependent functional and cognitive abilities, although not to the extent that was expected. The high prevalence of ophthalmic disorders highlights the need for periodic evaluations and individualized treatment plans for adults with Down syndrome, in general, but especially when concerns are identified. PMID:22570648

  13. Sophisticated instrumentation and ophthalmic ultrasonography.

    PubMed

    Buschmann, W

    1992-01-01

    Formerly, ophthalmic ultrasonography was leading in view of high-performance apparatuses and transducer probes: e.g., the first array-scanner in the world was built for ophthalmic use. Within the past 2 decades, however, high-tech innovations were merely developed for other medical specialties. These were studied in view of their use for ultrasonography of eye and orbit. The combination of B-scan and Doppler techniques facilitates detection of orbital vessels. The resolution of ophthalmic digital B-scan video images proved poorer than crt-B-scans. A digital memory, however, is advantageous. But one high-resolution crt-type B-scan needs more than one disc storage capacity. "Frontline digitalization" could help to reduce the amount of data. Array transducers are now available in small sizes and could better show structure movements, but they were not yet adapted to ophthalmic use. This applies as well to annular arrays and dynamic focusing. Different methods of 3-dimensional scanning and (Pseudo-) 3-dimensional imaging might renew Baum's and Coleman's early work. PMID:1332387

  14. Current Perspectives on Ophthalmic Mycoses

    PubMed Central

    Thomas, Philip A.

    2003-01-01

    Fungi may infect the cornea, orbit and other ocular structures. Species of Fusarium, Aspergillus, Candida, dematiaceous fungi, and Scedosporium predominate. Diagnosis is aided by recognition of typical clinical features and by direct microscopic detection of fungi in scrapes, biopsy specimens, and other samples. Culture confirms the diagnosis. Histopathological, immunohistochemical, or DNA-based tests may also be needed. Pathogenesis involves agent (invasiveness, toxigenicity) and host factors. Specific antifungal therapy is instituted as soon as the diagnosis is made. Amphotericin B by various routes is the mainstay of treatment for life-threatening and severe ophthalmic mycoses. Topical natamycin is usually the first choice for filamentous fungal keratitis, and topical amphotericin B is the first choice for yeast keratitis. Increasingly, the triazoles itraconazole and fluconazole are being evaluated as therapeutic options in ophthalmic mycoses. Medical therapy alone does not usually suffice for invasive fungal orbital infections, scleritis, and keratitis due to Fusarium spp., Lasiodiplodia theobromae, and Pythium insidiosum. Surgical debridement is essential in orbital infections, while various surgical procedures may be required for other infections not responding to medical therapy. Corticosteroids are contraindicated in most ophthalmic mycoses; therefore, other methods are being sought to control inflammatory tissue damage. Fungal infections following ophthalmic surgical procedures, in patients with AIDS, and due to use of various ocular biomaterials are unique subsets of ophthalmic mycoses. Future research needs to focus on the development of rapid, species-specific diagnostic aids, broad-spectrum fungicidal compounds that are active by various routes, and therapeutic modalities which curtail the harmful effects of fungus- and host tissue-derived factors. PMID:14557297

  15. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic...

  16. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic...

  17. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic...

  18. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic...

  19. 21 CFR 886.4230 - Ophthalmic knife test drum.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic...

  20. 21 CFR 886.4855 - Ophthalmic instrument table.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic instrument table. 886.4855 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4855 Ophthalmic instrument table. (a) Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic...

  1. In vitro testing of thiolated poly(aspartic acid) from ophthalmic formulation aspects.

    PubMed

    Budai-Szű Cs, Mária; Horvát, Gabriella; Gyarmati, Benjámin; Szilágyi, Barnabás Áron; Szilágyi, András; Csihi, Tímea; Berkó, Szilvia; Szabó-Révész, Piroska; Mori, Michela; Sandri, Giuseppina; Bonferoni, Maria Cristina; Caramella, Carla; Csányi, Erzsébet

    2016-08-01

    Ocular drug delivery formulations must meet anatomical, biopharmaceutical, patient-driven and regulatory requirements. Mucoadhesive polymers can serve as a better alternative to currently available ophthalmic formulations by providing improved bioavailability. If all requirements are addressed, a polymeric formulation resembling the tear film of the eye might be the best solution. The optimum formulation must not have high osmotic activity, should provide appropriate surface tension, pH and refractive index, must be non-toxic and should be transparent and mucoadhesive. We would like to highlight the importance of in vitro polymer testing from a pharmaceutical aspect. We, therefore, carried out physical-chemical investigations to verify the suitability of certain systems for ophthalmic formulations. In this work, in situ gelling, mucoadhesive thiolated poly(aspartic acid)s were tested from ophthalmic formulation aspects. The results of preformulation measurements indicate that these polymers can be used as potential carriers in ophthalmic drug delivery. PMID:26556306

  2. Sharps injuries in ophthalmic practice

    PubMed Central

    Ghauri, A-J; Amissah-Arthur, K N; Rashid, A; Mushtaq, B; Nessim, M; Elsherbiny, S

    2011-01-01

    Purpose Accidental sharps injuries are a potential route for transmission of blood-borne infection to healthcare workers. Ophthalmic staff in particular are at risk of sustaining such injuries due to the microsurgical nature of the speciality. Forthcoming European Union legislation aimed at reducing sharps injuries requires the development of risk-based sharps policy. The authors believe that this is the first study to assess the risks of sharps injuries and their management specific to ophthalmic practice within the European Union. Methods A retrospective review of all reported sharps injuries across three eye units in the UK over a period of 6 years was undertaken. Data were analysed to determine the circumstances surrounding the injury, occupation of the injured person, and whether appropriate actions were taken following incidents. Results A total of 68 sharps injuries were reported over the 6-year period. Nurses sustained 54.4% (n=37) of needlestick injuries, doctors 39.7% (n=27), and allied healthcare staff 5.9% (n=4). In all 51.5% (n=35) of sharps injuries occurred in the operating theatre, 30.9% (n=21) in the outpatient clinic, 13.2% (n=9) on the ophthalmic ward, and 4.4% (n=3) in unspecified locations. There was a median rate of 1.3 sharps injuries per 1000 surgical procedures per year and a range of 0.4–3.5 per 1000. Conclusions This study demonstrates the need to raise awareness of the unique risks of sharps injuries in ophthalmic practice. This is necessary in order to develop speciality-specific policy that promotes strategies to reduce such injuries, enhances the accuracy of reporting of such events, and provides guidance for appropriate management. PMID:21336251

  3. Ophthalmic Manifestations of Hematopoietic Malignancy.

    PubMed

    Yoshida-Hata, Natsuyo; Katai, Naomichi; Oshitari, Toshiyuki

    2016-01-01

    Purpose. To report the ocular findings in patients with hematopoietic malignancy with optic nerve involvement and abducens nerve palsy. Methods. The medical records of all cases of hematopoietic cancer with ophthalmic involvements seen in the Department of Ophthalmology of the National Center for Global Health and Medicine between 2009 and 2014 were reviewed. Results. Eight patients with hematopoietic cancer with optic nerve invasion or abducens nerve palsy were studied. The primary diseases were 3 cases of multiple myeloma, 1 case of acute lymphocytic leukemia, 1 case of follicular lymphoma, and 3 cases of AIDS-related lymphoma. Six cases had optic nerve invasion, 2 cases had abducens nerve palsy, and 1 case had optic nerve invasion of both eyes. The median visual acuity of eyes with optic nerve invasion was 0.885 logarithm of the minimum angle of resolution (logMAR) units. The final visual acuity of eyes with optic nerve invasion was 1.25 logMAR units, and that of those with sixth-nerve palsy was -0.1 logMAR units. Six cases died during the five-year follow-up period. An ophthalmic involvement in patients with hematopoietic cancer, especially AIDS-related lymphoma, was associated with poor prognosis. Conclusion. Because ophthalmic involvement in patients with hematopoietic malignancy has a poor prognosis, an early diagnosis of the cancers by the ophthalmologic findings by ophthalmologists could improve the prognosis. PMID:27375913

  4. Ophthalmic Manifestations of Hematopoietic Malignancy

    PubMed Central

    2016-01-01

    Purpose. To report the ocular findings in patients with hematopoietic malignancy with optic nerve involvement and abducens nerve palsy. Methods. The medical records of all cases of hematopoietic cancer with ophthalmic involvements seen in the Department of Ophthalmology of the National Center for Global Health and Medicine between 2009 and 2014 were reviewed. Results. Eight patients with hematopoietic cancer with optic nerve invasion or abducens nerve palsy were studied. The primary diseases were 3 cases of multiple myeloma, 1 case of acute lymphocytic leukemia, 1 case of follicular lymphoma, and 3 cases of AIDS-related lymphoma. Six cases had optic nerve invasion, 2 cases had abducens nerve palsy, and 1 case had optic nerve invasion of both eyes. The median visual acuity of eyes with optic nerve invasion was 0.885 logarithm of the minimum angle of resolution (logMAR) units. The final visual acuity of eyes with optic nerve invasion was 1.25 logMAR units, and that of those with sixth-nerve palsy was −0.1 logMAR units. Six cases died during the five-year follow-up period. An ophthalmic involvement in patients with hematopoietic cancer, especially AIDS-related lymphoma, was associated with poor prognosis. Conclusion. Because ophthalmic involvement in patients with hematopoietic malignancy has a poor prognosis, an early diagnosis of the cancers by the ophthalmologic findings by ophthalmologists could improve the prognosis. PMID:27375913

  5. Ophthalmic lymphoma: epidemiology and pathogenesis.

    PubMed

    Sjö, Lene Dissing

    2009-02-01

    With a lifetime risk of 1% and 700 new cases per year, Non-Hodgkin lymphoma (NHL) is the seventh most frequent type of cancer in Denmark. The incidence of NHL has increased considerably in Western countries over the last decades; consequently, NHL is an increasing clinical problem. Ophthalmic lymphoma, (lymphoma localized in the ocular region, i.e. eyelid, conjunctiva, lacrimal sac, lacrimal gland, orbit, or intraocularly) is relatively uncommon, accounting for 5%-10% of all extranodal lymphomas. It is, however, the most common orbital malignancy. The purpose of this thesis was to review specimens from all Danish patients with a diagnosis of ophthalmic lymphoma during the period 1980-2005, in order to determine the distribution of lymphoma subtypes, and the incidence- and time trends in incidence for ophthalmic lymphoma. Furthermore, an extended analysis of the most frequent subtype, extranodal marginal zone lymphoma (MALT lymphoma), was done to analyse clinical factors and cytogenetic changes with influence on prognosis. A total of 228 Danish patients with a biopsy-reviewed verified diagnosis of ocular adnexal-, orbital-, or intraocular lymphoma were identified. We found that more than 50% of orbital- and ocular adnexal lymphomas were of the MALT lymphoma subtype, whereas diffuse large B-cell lymphoma (DLBCL) predominated intraocularly (Sjo et al. 2008a). Furthermore, lymphoma arising in the lacrimal sac was surprisingly predominantly DLBCL (Sjo et al. 2006). Incidence rates were highly dependent on patient age. There was an increase in incidence rates for the whole population from 1980 to 2005, corresponding to an annual average increase of 3.4% (Sjo et al. 2008a). MALT lymphoma arising in the ocular region was found in 116 patients (Sjo et al. 2008b). One third of patients had a relapse or progression of disease after initial therapy and relapses were frequently found at extra-ocular sites. Overall survival, however, was not significantly poorer for patients

  6. Mini Drug Pump for Ophthalmic Use

    PubMed Central

    Saati, Saloomeh; Lo, Ronalee; Li, Po-Ying; Meng, Ellis; Varma, Rohit; Humayun, Mark S.

    2009-01-01

    Purpose: To evaluate the feasibility of developing a novel mini drug pump for ophthalmic use. Methods: Using principles of microelectromechanical systems engineering, a mini drug pump was fabricated. The pumping mechanism is based on electrolysis, and the pump includes a drug refill port as well as a check valve to control drug delivery. Drug pumps were tested first on the benchtop and then after implantation in rabbits. For the latter, we implanted 4 elliptical (9.9 × 7.7 × 1.8 mm) non-electrically active pumps into 4 rabbits. The procedure is similar to implantation of a glaucoma seton. To determine the ability to refill and also the patency of the cannula, at intervals of 4 to 6 weeks after implantation, we accessed the drug reservoir with a transconjunctival needle and delivered approximately as low as 1 μL of trypan blue solution (0.06%) into the anterior chamber. Animals were followed up by slit-lamp examination, photography, and fluorescein angiography. Results: Benchtop testing showed 2.0 μL/min delivery when using 0.4 mW of power for electrolysis. One-way valves showed reliable opening pressures of 470 mm Hg. All implanted devices refilled at 4- to 6-week intervals for 4 to 6 months. No infection was seen. No devices extruded. No filtering bleb formed over the implant. Conclusions: A prototype ocular mini drug pump was built, implanted, and refilled. Such a platform needs more testing to determine the long-term biocompatibility of an electrically controlled implanted pump. Testing with various pharmacologic agents is needed to determine its ultimate potential for ophthalmic use. PMID:20126483

  7. 21 CFR 349.10 - Ophthalmic astringent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic astringent. 349.10 Section 349.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.10...

  8. 21 CFR 349.12 - Ophthalmic demulcents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic demulcents. 349.12 Section 349.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.12...

  9. Viscoelastic interactions between polydeoxyribonucleotide and ophthalmic excipients.

    PubMed

    Kim, Iksoo; Kim, Hyeongmin; Park, Kyunghee; Karki, Sandeep; Khadka, Prakash; Jo, Kanghee; Kim, Seong Yeon; Ro, Jieun; Lee, Jaehwi

    2016-01-01

    This study investigated the interaction between polydeoxyribonucleotide (PDRN) and several ionic and nonionic isotonic agents, thickeners and a preservative that were employed as excipients in ophthalmic preparations. Interaction of each individual excipient and PDRN aqueous solution was evaluated by analyzing their rheological properties. Rheological properties of PDRN solutions were evaluated by dynamic oscillatory shear tests and values of elastic modulus (G'), viscous modulus (G″) and loss tangent (tan δ) were used to assess the relative changes in viscoelastic properties. At given concentrations, sodium chloride was found to show alteration in viscoelastic properties of PDRN solution while nonionic isotonic agents like d-glucose and d-sorbitol did not alter them. Similarly, nonionic water soluble polymers like polyvinylpyrrolidone (PVP) and hydroxypropyl methylcellulose (HPMC) also did not interact with PDRN to alter the viscoelastic properties. However, there were changes observed when carbopol 940 was used as a thickener. Therefore, PDRN was found to interact with ionic excipients and the interactions were negligible when nonionic materials were examined, which suggests that nonionic excipients are suitable to be formulated with PDRN. PMID:26023993

  10. 21 CFR 886.4770 - Ophthalmic operating spectacles (loupes).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic operating spectacles (loupes). 886.4770... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4770 Ophthalmic operating spectacles (loupes). (a) Identification. Ophthalmic operating spectacles (loupes) are devices that consist of...

  11. 21 CFR 886.4770 - Ophthalmic operating spectacles (loupes).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic operating spectacles (loupes). 886.4770... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4770 Ophthalmic operating spectacles (loupes). (a) Identification. Ophthalmic operating spectacles (loupes) are devices that consist of...

  12. 21 CFR 886.4770 - Ophthalmic operating spectacles (loupes).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic operating spectacles (loupes). 886.4770... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4770 Ophthalmic operating spectacles (loupes). (a) Identification. Ophthalmic operating spectacles (loupes) are devices that consist of...

  13. 21 CFR 886.4770 - Ophthalmic operating spectacles (loupes).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic operating spectacles (loupes). 886.4770... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4770 Ophthalmic operating spectacles (loupes). (a) Identification. Ophthalmic operating spectacles (loupes) are devices that consist of...

  14. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  15. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  16. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  17. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  18. 21 CFR 886.5100 - Ophthalmic beta radiation source.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic beta radiation source. 886.5100 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5100 Ophthalmic beta radiation source. (a) Identification. An ophthalmic beta radiation source is a device intended to apply...

  19. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to...

  20. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to...

  1. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to...

  2. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to...

  3. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic isotope uptake probe. 886.1670 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1670 Ophthalmic isotope uptake probe. (a) Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to...

  4. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted...

  5. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted...

  6. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted...

  7. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted...

  8. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  9. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of...

  10. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  11. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  12. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of...

  13. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  14. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  15. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  16. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of...

  17. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of...

  18. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  19. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  20. 21 CFR 886.1420 - Ophthalmic lens gauge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of...

  1. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  2. 21 CFR 886.5810 - Ophthalmic prism reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine...

  3. 21 CFR 886.5810 - Ophthalmic prism reader.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine...

  4. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld...

  5. 21 CFR 886.1655 - Ophthalmic Fresnel prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings...

  6. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld...

  7. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld...

  8. 21 CFR 886.1655 - Ophthalmic Fresnel prism.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings...

  9. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld...

  10. 21 CFR 886.1655 - Ophthalmic Fresnel prism.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings...

  11. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually...

  12. 21 CFR 886.1655 - Ophthalmic Fresnel prism.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings...

  13. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually...

  14. 21 CFR 886.1655 - Ophthalmic Fresnel prism.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic Fresnel prism. 886.1655 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1655 Ophthalmic Fresnel prism. (a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings...

  15. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually...

  16. 21 CFR 886.1665 - Ophthalmic rotary prism.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic rotary prism. 886.1665 Section 886.1665...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1665 Ophthalmic rotary prism. (a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld...

  17. 21 CFR 886.5810 - Ophthalmic prism reader.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine...

  18. 21 CFR 886.5810 - Ophthalmic prism reader.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine...

  19. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually...

  20. 21 CFR 886.5810 - Ophthalmic prism reader.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic prism reader. 886.5810 Section 886.5810...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5810 Ophthalmic prism reader. (a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine...

  1. 21 CFR 886.1650 - Ophthalmic bar prism.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually...

  2. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  3. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  4. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  5. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  6. 21 CFR 886.4750 - Ophthalmic eye shield.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended...

  7. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar reader. 886.5800 Section...

  8. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic bar reader. 886.5800 Section...

  9. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic bar reader. 886.5800 Section...

  10. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic bar reader. 886.5800 Section...

  11. 21 CFR 886.5800 - Ophthalmic bar reader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic bar reader. 886.5800 Section...

  12. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  13. 21 CFR 886.4570 - Ophthalmic surgical marker.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic surgical marker. 886.4570 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4570 Ophthalmic surgical marker. (a) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation...

  14. 21 CFR 886.1860 - Ophthalmic instrument stand.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic instrument stand. 886.1860 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1860 Ophthalmic instrument stand. (a) Identification. An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store...

  15. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic tantalum clip. 886.3100 Section 886.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is...

  16. 21 CFR 886.4350 - Manual ophthalmic surgical instrument.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual ophthalmic surgical instrument. 886.4350... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4350 Manual ophthalmic surgical instrument. (a) Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld...

  17. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to...

  18. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to...

  19. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to...

  20. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to...

  1. 21 CFR 886.4250 - Ophthalmic electrolysis unit.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic electrolysis unit. 886.4250 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4250 Ophthalmic electrolysis unit. (a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to...

  2. Big data and ophthalmic research.

    PubMed

    Clark, Antony; Ng, Jonathon Q; Morlet, Nigel; Semmens, James B

    2016-01-01

    Large population-based health administrative databases, clinical registries, and data linkage systems are a rapidly expanding resource for health research. Ophthalmic research has benefited from the use of these databases in expanding the breadth of knowledge in areas such as disease surveillance, disease etiology, health services utilization, and health outcomes. Furthermore, the quantity of data available for research has increased exponentially in recent times, particularly as e-health initiatives come online in health systems across the globe. We review some big data concepts, the databases and data linkage systems used in eye research-including their advantages and limitations, the types of studies previously undertaken, and the future direction for big data in eye research. PMID:26844660

  3. Dry Eye and Designer Ophthalmics

    PubMed Central

    Laurie, Gordon W.; Olsakovsky, Leslie A.; Conway, Brian P.; McKown, Robert L.; Kitagawa, Kazuko; Nichols, Jason J.

    2009-01-01

    EST, proteomic, and antibody capture assays are revealing a level of tear film protein complexity far greater than previously appreciated. A systems biology approach will be needed to fully appreciate function as tear protein doses fluctuate in time through different conditions. Although consensus is growing on what fully constitutes the human tear proteome, questions remain about the source and significance of the ∼256 tear proteins designated as ‘intracellular’. Many of these may derive from normal cellular turnover and could therefore be informative. A further >183 are designated as ‘extracellular’. Surprisingly, only 4 – 5% of these appear to be dysregulated in the three forms of dry eye preliminarily examined to date. Some differ and a couple overlap, suggesting that disease-specific signatures could be identified. Future dry eye treatment might include recombinant tear protein rescue as a personalized ophthalmic approach to ocular surface disease. PMID:18677231

  4. [Ophthalmic manifestations of Huntington's disease].

    PubMed

    Svetozarskiy, S N; Kopishinskaya, S V; Gustovy, A V; Radyuk, M A; Antonova, V A; Smetankin, I G

    2015-01-01

    Huntington's disease (HD) is an autosomal dominant neurodegenerative disorder caused by a mutation in the huntingtin gene. The whole nervous system, including visual analyzer, is involved in the pathogenesis of the disease. Various ocular sings can be found in both preclinical and clinical stages of HD. Specific retinal damage, namely, abnormal proteins formation, photoreceptor degeneration and retinal remodeling, has been studied in animal models. Functional changes in occipital lobe activity and its atrophy as well as degeneration of visual pathways can already be present in the early stages of the disease. Oculomotor symptoms of HD include disturbed visual fixation, slower tracking eye movements and saccades, and suppressed vestibulo-ocular reflex. Visual perceptual disorders, such as visuospatial difficulties, problems of stimulus identification and motion perception, along with decreased contrast sensitivity, have also been described. The possibility of using certain ophthalmic parameters as biomarkers of HD is being discussed. PMID:26845877

  5. Ophthalmic statistics note 5: diagnostic tests—sensitivity and specificity

    PubMed Central

    Saunders, Luke J; Zhu, Haogang; Bunce, Catey; Doré, Caroline J; Freemantle, Nick; Crabb, David P

    2015-01-01

    This is the fifth statistics note produced by the Ophthalmic Statistics Group (OSG) which is designed to be a simple guide to ophthalmic researchers on a statistical issue with an applied ophthalmic example. The OSG is a collaborative group of statisticians who have come together with a desire to raise the statistical standards of ophthalmic researcher by increasing statistical awareness of common issues. PMID:25488948

  6. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

  7. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

  8. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

  9. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

  10. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

  11. 21 CFR 524.1484a - Neomycin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Neomycin sulfate ophthalmic ointment. 524.1484a... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1484a Neomycin sulfate ophthalmic ointment. (a) Specifications. Each gram of the ointment...

  12. 21 CFR 524.575 - Cyclosporine ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Cyclosporine ophthalmic ointment. 524.575 Section... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.575 Cyclosporine ophthalmic ointment. (a) Specifications. Each gram of ointment contains...

  13. 21 CFR 886.4770 - Ophthalmic operating spectacles (loupes).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic operating spectacles (loupes). 886.4770 Section 886.4770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4770 Ophthalmic operating spectacles (loupes). (a) Identification....

  14. 21 CFR 349.16 - Ophthalmic hypertonicity agent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ophthalmic hypertonicity agent. 349.16 Section 349.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.16 Ophthalmic hypertonicity agent. The...

  15. Recent advances in ophthalmic molecular imaging.

    PubMed

    Ramos de Carvalho, J Emanuel; Verbraak, Frank D; Aalders, Maurice C; van Noorden, Cornelis J; Schlingemann, Reinier O

    2014-01-01

    The aim of molecular imaging techniques is the visualization of molecular processes and functional changes in living animals and human patients before morphological changes occur at the cellular and tissue level. Ophthalmic molecular imaging is still in its infancy and has mainly been used in small animals for pre-clinical research. The goal of most of these pre-clinical studies is their translation into ophthalmic molecular imaging techniques in clinical care. We discuss various molecular imaging techniques and their applications in ophthalmology. PMID:24529711

  16. 21 CFR 886.4690 - Ophthalmic photocoagulator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic photocoagulator. 886.4690 Section 886.4690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... noncoherent light source to occlude blood vessels of the retina, choroid, or iris. (b) Classification....

  17. 21 CFR 886.4690 - Ophthalmic photocoagulator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ophthalmic photocoagulator. 886.4690 Section 886.4690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... noncoherent light source to occlude blood vessels of the retina, choroid, or iris. (b) Classification....

  18. 21 CFR 886.1640 - Ophthalmic preamplifier.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic preamplifier. 886.1640 Section 886.1640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction...

  19. 21 CFR 886.1760 - Ophthalmic refractometer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ophthalmic refractometer. 886.1760 Section 886.1760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general...

  20. Design of ophthalmic lens by using optimized aspheric surface coefficients

    NASA Astrophysics Data System (ADS)

    Chang, Ming-Wen; Sun, Wen-Shing; Tien, Chuen-Lin

    1998-09-01

    Coddington's equations can be used to eliminate the oblique astigmatic error in the design of ophthalmic lens of spherical or other conicoidal surfaces. But it is difficult to get satisfactory result in the designing of the nonconic aspheric ophthalmic lens. In this paper we present an efficient approach based on optimization of aspheric coefficients, which enables the design program to obtain the minimum aberrations. Many higher order coefficients of aspheric surfaces can easily result in inflection point, which increases the difficulty in manufacturing. We solved the problem by taking it as one of the optimization constraints. The design of nonconic aspheric ophthalmic lens could also make the spectacle lenses well thinner in thickness and well flatter in shape than the design of spherical ophthalmic lens and other conicoidal ophthalmic lens. Damped least square methods are used in our design. Aspherical myopia ophthalmic lenses, aspherical hypermetropic lenses and cataract lenses were designed. Comparisons of design examples' results are given.

  1. A new kind of monitor for ophthalmic operation

    NASA Astrophysics Data System (ADS)

    Li, G.; Wang, L. L.; Wang, Y.; Lin, L.; Jiang, W.; C-Y Lu, Stephen; Besio, Walter G.

    2005-01-01

    The integrity of the vision channel is often checked using VEP in order to avoiding damaging important tissue during an ophthalmic operation. But the measurement of before operations has strong side effects, it may damage the eyeball. We will introduce a new kind for monitoring ophthalmic operations in this paper. It uses visual electrical evoked potential to check the integrity of the vision access and it can monitor ophthalmic operations and avoid damaging any tissue, so it ensures the safety of the operation.

  2. Investigation of Somatic GNAQ, GNA11, BAP1 and SF3B1 Mutations in Ophthalmic Melanocytomas

    PubMed Central

    Francis, Jasmine H.; Wiesner, Thomas; Milman, Tatyana; Won, Helen H.; Lin, Amy; Lee, Vivian; Albert, Daniel M.; Folberg, Robert; Berger, Michael F.; Char, Devron H.; Marr, Brian; Abramson, David H.

    2016-01-01

    Purpose The aim of this study was to use massively parallel DNA sequencing to identify GNAQ/11, BAP1 and SF3B1 mutations in ophthalmic melanocytoma. Procedures Six ophthalmic melanocytoma specimens (1 iridociliary and 5 optic nerve) were profiled for genomic alterations in GNAQ/11, BAP1 and SF3B1 using a custom deep sequencing assay. This assay uses solution phase hybridization-based exon capture and deep-coverage massively parallel DNA sequencing to interrogate all protein-coding exons and select introns. Results The only iridociliary melanocytoma showed a mutation in GNAQ but not in BAP1. Of the 2 optic-nerve melanocytomas that developed into melanoma, one had a GNAQ mutation and both a BAP1 mutation and monosomy 3. The remaining 3 optic-nerve melanocytomas did not reveal mutations in GNAQ/11 or BAP1. SF3B1 mutations were not detected in any specimen. Conclusions The presence of GNAQ mutation in some iridociliary and optic-nerve melanocytomas suggests a possible relationship between ophthalmic melanocytoma and other ophthalmic melanocytic neoplasms. BAP1 mutation may accompany the transformation of ophthalmic melanocytoma to melanoma. PMID:27239460

  3. Laser technologies in ophthalmic surgery

    NASA Astrophysics Data System (ADS)

    Atezhev, V. V.; Barchunov, B. V.; Vartapetov, S. K.; Zav’yalov, A. S.; Lapshin, K. E.; Movshev, V. G.; Shcherbakov, I. A.

    2016-08-01

    Excimer and femtosecond lasers are widely used in ophthalmology to correct refraction. Laser systems for vision correction are based on versatile technical solutions and include multiple hard- and software components. Laser characteristics, properties of laser beam delivery system, algorithms for cornea treatment, and methods of pre-surgical diagnostics determine the surgical outcome. Here we describe the scientific and technological basis for laser systems for refractive surgery developed at the Physics Instrumentation Center (PIC) at the Prokhorov General Physics Institute (GPI), Russian Academy of Sciences.

  4. 21 CFR 349.16 - Ophthalmic hypertonicity agent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic hypertonicity agent. 349.16 Section 349.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Ophthalmic hypertonicity agent. The active ingredient and its concentration in the product is as...

  5. 21 CFR 524.390 - Chloramphenicol ophthalmic ointment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Chloramphenicol ophthalmic ointment. 524.390... § 524.390 Chloramphenicol ophthalmic ointment. (a) Specifications. Each gram contains 10 milligrams chloramphenicol. (b) Sponsors. See Nos. 043264 and 054771 in § 510.600(c) of this chapter. (c) Conditions of...

  6. 21 CFR 524.390 - Chloramphenicol ophthalmic ointment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Chloramphenicol ophthalmic ointment. 524.390... § 524.390 Chloramphenicol ophthalmic ointment. (a) Specifications. Each gram contains 10 milligrams chloramphenicol. (b) Sponsors. See Nos. 000856 and 043264 in § 510.600(c) of this chapter. (c) Conditions of...

  7. 21 CFR 524.390 - Chloramphenicol ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Chloramphenicol ophthalmic ointment. 524.390... § 524.390 Chloramphenicol ophthalmic ointment. (a) Specifications. Each gram contains 10 milligrams chloramphenicol. (b) Sponsors. See Nos. 000856 and 025463 in § 510.600(c) of this chapter. (c) Conditions of...

  8. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 025463...

  9. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 025463...

  10. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 043264...

  11. 21 CFR 524.1044c - Gentamicin sulfate ophthalmic ointment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Gentamicin sulfate ophthalmic ointment. 524.1044c... § 524.1044c Gentamicin sulfate ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 025463...

  12. 21 CFR 524.1044c - Gentamicin ophthalmic ointment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Gentamicin ophthalmic ointment. 524.1044c Section... § 524.1044c Gentamicin ophthalmic ointment. (a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin. (b) Sponsors. See Nos. 000061 and 043264...

  13. Ophthalmic contributions of Raja Serfoji II (1798–1832)

    PubMed Central

    Biswas, Jyotirmay; Badrinath, Vasanthi; Badrinath, Sengamedu S

    2012-01-01

    Purpose: To investigate and describe the ophthalmic contribution of Raja Serfoji II (1798-1832). Materials and Method: A team of 2 ophthalmologists, director of laboratory services, one archeologist and a photographer visited Sarasvathi Mahal Library, March 2004. Photographs of ophthalmic records were taken and analysed. An interview of the present prince, S Babaji Rajah Bhonsle was taken. Ophthalmologic case sheets of 44 patients, 18 pictures were found. Results: Forty-four patient's ophthalmic records were found. Six records were written in Modi script, 38 were written in English and 18 drawings were found. Conclusion: In Thanjavur, King Serfoji II carried out methodical ophthalmic practices between 1798 and 1832. Both European and Indian medicines were used. Cataract Surgery was performed. Detailed ophthalmic records were maintained. The only evidence of Serfoji's amazing contribution to medicine lies in 50 charts and manuscripts. PMID:22824599

  14. Adjustable fluidic lenses for ophthalmic corrections

    PubMed Central

    Marks, Randall; Mathine, David L.; Peyman, Gholam; Schwiegerling, Jim; Peyghambarian, Nasser

    2010-01-01

    We report on two fluidic lenses that have been developed for ophthalmic applications. The lenses use a circular aperture to demonstrate optical powers between −20 and +20 D and a rectangular aperture to demonstrate astigmatism with values ranging from 0 to 8 D. Measurements of image quality were made with the fluidic lens using a model eye. Both lenses were variable and controllable by adjusting the fluid volume of the lens. To the best of our knowledge this is the first demonstration of a continuously variable lens for control of astigmatism. PMID:19373359

  15. Programmable diffractive lens for ophthalmic application

    NASA Astrophysics Data System (ADS)

    Millán, María S.; Pérez-Cabré, Elisabet; Romero, Lenny A.; Ramírez, Natalia

    2014-06-01

    Pixelated liquid crystal displays have been widely used as spatial light modulators to implement programmable diffractive optical elements, particularly diffractive lenses. Many different applications of such components have been developed in information optics and optical processors that take advantage of their properties of great flexibility, easy and fast refreshment, and multiplexing capability in comparison with equivalent conventional refractive lenses. We explore the application of programmable diffractive lenses displayed on the pixelated screen of a liquid crystal on silicon spatial light modulator to ophthalmic optics. In particular, we consider the use of programmable diffractive lenses for the visual compensation of refractive errors (myopia, hypermetropia, astigmatism) and presbyopia. The principles of compensation are described and sketched using geometrical optics and paraxial ray tracing. For the proof of concept, a series of experiments with artificial eye in optical bench are conducted. We analyze the compensation precision in terms of optical power and compare the results with those obtained by means of conventional ophthalmic lenses. Practical considerations oriented to feasible applications are provided.

  16. National Strategies of Ophthalmic Education in Iran

    PubMed Central

    Entezari, A; Javadi, MA; Einollahi, B

    2012-01-01

    Background: Academic medicine is in a state of dramatic transformation. For this reason strategic thinking is the most essential part of educational planning. The main purpose of the present study was developing the strategic educational planning of Ophthalmology in Iran from 2007 to 2010 Methods: A qualitative investigation using focus group discussion has been implemented successfully for developing educational planning. Six to twelve representatives of key stakeholders in the ophthalmic education of Iran participated to this study. Results: Strengths, weaknesses, opportunities and threats of ophthalmology education in Iran were analyzed. Strategic goals in education, research, and health service providing domains were being developed. Educational goals were defined as training of human resources in accordance with the community needs at the level of general practitioner, specialist, and fellowships in ophthalmology. Research goals of the program were defined as scientific inter-departmental and international communications, in order to promote the level of education, research, and treatment in the country. Also, in the field of health services according to the community needs, providing services by the means of advanced and cost effective methods were defined as strategic objectives. Conclusion: Based on this strategic plan in the last three years ophthalmic education in Iran shall be many changes in educational, research and health care provision for social accountability. PMID:23113125

  17. Development and characterization of in-situ gel for ophthalmic formulation containing ciprofloxacin hydrochloride

    PubMed Central

    Makwana, S.B.; Patel, V.A.; Parmar, S.J.

    2015-01-01

    In situ gels are systems which are applied as solutions or suspensions and are capable of undergoing rapid sol-to-gel transformation triggered by external stimulus such as temperature, pH etc. on instillation. The aim of the present study was to formulate and evaluate pH responsive in-situ gel for ophthalmic delivery. Ciprofloxacin hydrochloride is popularly used as a broad spectrum antibiotic in the treatment of corneal ulcers of ocular infections. However, rapid dilution on instillation, wash out, poor retention of drug concentration delimit the therapeutic benefits of the drug when used in form of conventional eye drops. Sodium alginate, an ophthalmic gel forming mucoadhesive polymer was chosen as polymer which undergoes instantaneous gel formation due to formation of calcium alginate by virtue of its interaction with divalent cation (Ca+2) present in lachrymal fluid. Hydroxy Propyl Methyl Cellulose (HPMC K4M and E5 0LV) was further incorporated as a viscosity enhancer in order to achieve the desired consistency so as to facilitate sustained drug release. The developed formulations were evaluated for clarity, pH measurement, gelling capacity, drug content, rheological study, and in vitro drug release. Thus, in situ gel based systems containing gums can be a valuable approach for ophthalmic drug delivery when compared to conventional systems. PMID:26949596

  18. Simple HPLC determination of benzalkonium chloride in ophthalmic formulations containing antazoline and tetrahydrozoline.

    PubMed

    Rojsitthisak, Pornchai; Wichitnithad, Wisut; Pipitharome, Ongart; Sanphanya, Kingkan; Thanawattanawanich, Peeracha

    2005-01-01

    A simple and rapid analytical procedure for routine quantification of n-C12H25 and n-C14H29 benzalkonium chloride (C-12 and C-14 BKC) homologs in ophthalmic formulations containing antazoline HCl and tetrahydrozoline HCl by high-performance liquid chromatography was developed and validated. The ophthalmic solution samples can be directly analyzed by reversed-phase on HiQ-Sil C18 column (4.6 mm x 150 mm, i.d., 5-microm particle size) with acetonitrile-sodium acetate buffer (pH 5.0; 0.2 M) (70:30, v/v) as mobile phase. UV Detection was carried out at 262 nm. The method was linear over the selected concentration and ranged from 0.03 to 0.10 mg/ml (r2 = 0.9999) and from 0.01 to 0.05 mg/ml (r2 = 0.9979) for C-12 and C-14 BKC homologs, respectively. The mean percent recoveries were 100.2 and 102.6 and the percent CV values were 1.3 and 3.5 for C-12 and C-14 BKC homologs, respectively. The results demonstrated the good linearity, accuracy, and precision. The method was applied to determine two commercial ophthalmic formulations, and the percent label amounts of total BKC contents were found to be 99.7 and 103.2. PMID:16316068

  19. Preeclampsia and Future Risk for Maternal Ophthalmic Complications.

    PubMed

    Beharier, Ofer; Davidson, Ehud; Sergienko, Ruslan; Szaingurten-Solodkin, Irit; Kessous, Roy; Charach, Ron; Belfair, Nadav J; Sheiner, Eyal

    2016-06-01

    Objective To investigate whether patients with a history of preeclampsia have an increased risk of long-term ophthalmic complications. Study Design A population-based study comparing the incidence of long-term maternal ophthalmic complications in a cohort of women with and without a history of preeclampsia. Results During the study period, a total of 103,183 deliveries met the inclusion criteria; 8.1% (n = 8,324) occurred in patients with a diagnosis of preeclampsia during at least one of their pregnancies. Patients with preeclampsia had a significantly higher incidence of long-term ophthalmic morbidity such as diabetic retinopathy and retinal detachment. In addition, a positive linear correlation was found between the severity of preeclampsia and the prevalence of future ophthalmic morbidities (0.3 vs. 0.5 vs. 2.2%, respectively). Kaplan-Meier survival curve indicated that women with preeclampsia had higher rates of total ophthalmic morbidity (0.2 vs. 0.4%, for no preeclampsia and with preeclampsia, respectively; odds ratio = 2.06, 95% confidence interval: 1.42-2.99; p < 0.001). In a Cox proportional hazards model, adjusted for confounders, a history of preeclampsia remained independently associated with ophthalmic complications. Conclusion Preeclampsia is an independent risk factor for long-term maternal ophthalmic morbidity, specifically diabetic retinopathy and retinal detachment. This risk is more substantial depending on the severity of the disease. PMID:26871904

  20. Neuro-Ophthalmic Syndromes and Processing Speed in Multiple Sclerosis.

    PubMed

    Costa, Silvana L; Gonçalves, Óscar F; Chiaravalloti, Nancy D; DeLuca, John; Almeida, Jorge

    2016-03-01

    The impact of prior neuro-ophthalmic syndromes on the performance on vision-based neuropsychological tasks in patients with multiple sclerosis (MS) is unknown. Two groups of MS participants, one with (Msos+) and the other without (Msos-), a history of neuro-ophthalmic syndromes, underwent neuropsychological assessment and were compared with healthy age- and education-matched controls (HC). Participants with Msos+ performed significantly worse on the symbol digit modalities test than the Msos- (P < 0.03) and the HC groups (P < 0.01) and coding (P < 0.01). A clinical history of neuro-ophthalmic syndromes is associated with reduced performance on visual processing speed tasks. PMID:26132964

  1. Fasting regimens for regional ophthalmic anaesthesia. A survey of members of the British Ophthalmic Anaesthesia Society.

    PubMed

    Steeds, C; Mather, S J

    2001-07-01

    Members of the British Ophthalmic Anaesthesia Society were surveyed using a postal questionnaire. The response rate was 72.3%. Respondents were asked about starvation before regional anaesthesia for cataract surgery, the use of sedation in these patients, monitoring and if oxygen supplementation was given. The results show that most patients are not starved before this type of regional anaesthesia, and that the majority of patients receive no supplementary sedation or intravenous analgesia. Over 70% of patients received oxygen supplementation. PMID:11437763

  2. Ocular and systemic adverse effects of ophthalmic and non ophthalmic medications.

    PubMed

    Izazola-Conde, C; Zamora-de la Cruz, D; Tenorio-Guajardo, G

    2011-01-01

    Information related to adverse drug effects caused by ocular medications and ocular adverse effects of systemically administered drugs has increased over the last several decades. Here we review the medical literature over the last four decades to both quantitatively and qualitatively determine the adverse effects of ocular drugs and ocular toxicity of non-ocular drugs. A systematic bibliographic review of the literature was performed with the following terms: "drug treatment", "drug therapy", "ocular adverse effects", "ocular side effects", "ocular toxicity", "systemic side effects", "systemic adverse effects", "systemic toxicity", "ocular drug" and "ophthalmic drug" using the Boolean operators or, and, not. Searches focused on: (1) Ocular side/adverse effects of ophthalmic drugs; (2) Ocular side/adverse effects of systemic drugs; (3) Systemic side/adverse effects of ophthalmic drugs. PubMed was used to perform searches. Limits included: species, human and field tag, abstract/title, dates from 01/01/1971 to 31/12/2010. A sub-selection of references was made by discarding articles that were irrelevant for the topics listed above. Adverse effects of alpha2-adrenergic agonists, beta-adrenergic antagonists, quinine derivatives and antituberculosis agents appear in the literature throughout the period of the review. Adverse effects of newer drugs such as amiodarone, phosphodiesterase 5 inhibitors, antiepileptics, tamoxifen, and its interactions have been published principally in the last two decades. It is imperative for patient safety that knowledge of the adverse effects of drugs on the eye whether topically or systemically administered, and the possible systemic effects of drugs given as ophthalmic medications be emphasized to clinicians. PMID:22423585

  3. An historical ophthalmic study of Jane Austen.

    PubMed

    Wilson, Graham A

    2012-11-01

    Today, no other classic novelist has the popularity or power of Jane Austen, and in 2013 the world will celebrate 200 years of her comic masterpiece Pride and Prejudice. Her millions of fans have an abiding fascination with all aspects of her life, including her health and the cause of her death. This historical ophthalmic study of Jane Austen, based on very incomplete medical bibliographic data, finds that she had a mild ocular surface disorder from age 23. This disorder did not significantly impact on her visual performance for writing. There are many references to eyes in her novels, but Jane's eyes and those of her characters cannot contribute further to the debate around the cause of her death at age 41. PMID:22923461

  4. M-sequences in ophthalmic electrophysiology.

    PubMed

    Müller, Philipp L; Meigen, Thomas

    2016-01-01

    The aim of this review is to use the multimedia aspects of a purely digital online publication to explain and illustrate the highly capable technique of m-sequences in multifocal ophthalmic electrophysiology. M-sequences have been successfully applied in clinical routines during the past 20 years. However, the underlying mathematical rationale is often daunting. These mathematical properties of m-sequences allow one not only to separate the responses from different fields but also to analyze adaptational effects and impacts of former events. By explaining the history, the formation, and the different aspects of application, a better comprehension of the technique is intended. With this review we aim to clarify the opportunities of m-sequences in order to motivate scientists to use m-sequences in their future research. PMID:26818968

  5. Numerical Modeling of Ophthalmic Response to Space

    NASA Technical Reports Server (NTRS)

    Nelson, E. S.; Myers, J. G.; Mulugeta, L.; Vera, J.; Raykin, J.; Feola, A.; Gleason, R.; Samuels, B.; Ethier, C. R.

    2015-01-01

    To investigate ophthalmic changes in spaceflight, we would like to predict the impact of blood dysregulation and elevated intracranial pressure (ICP) on Intraocular Pressure (IOP). Unlike other physiological systems, there are very few lumped parameter models of the eye. The eye model described here is novel in its inclusion of the human choroid and retrobulbar subarachnoid space (rSAS), which are key elements in investigating the impact of increased ICP and ocular blood volume. Some ingenuity was required in modeling the blood and rSAS compartments due to the lack of quantitative data on essential hydrodynamic quantities, such as net choroidal volume and blood flowrate, inlet and exit pressures, and material properties, such as compliances between compartments.

  6. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) of this chapter. (c) Conditions of use. It is indicated for use in dogs in various eye infections due..., removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3... least 48 hours after the eye appears normal. For use only by or on the order of a licensed veterinarian....

  7. 21 CFR 524.1200b - Kanamycin ophthalmic aqueous solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) of this chapter. (c) Conditions of use. It is indicated for use in dogs in various eye infections due..., removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3... least 48 hours after the eye appears normal. For use only by or on the order of a licensed veterinarian....

  8. 21 CFR 524.1200b - Kanamycin ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... chapter. (c) Conditions of use in dogs—(1) Amount. Instill a few drops into the affected eye every 3 hours... 48 hours after the eye appears normal. (2) Indications for use. For the treatment of various...

  9. 21 CFR 524.1982 - Proparacaine ophthalmic solution.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected; as an... intraocular pressure (tonometry) when glaucoma is suspected. Local applications may also be used as an aid...

  10. 21 CFR 524.390b - Chloramphenicol ophthalmic solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Limitations. Therapy for cats should not exceed 7 days. As with other antibiotics, prolonged use may result in... within a reasonable period, discontinue use, and institute appropriate therapy. Prolonged use in cats...